Thermo Fisher Scientific Inc jobs

<p><br></p><p><b>DESCRIPTION</b>: Join our team as a Senior Sales Manager at Thermo Fisher Scientific, where you'll guide and develop commercial teams to drive strategic growth across our innovative portfolio. You'll be responsible for implementing effective sales strategies, achieving revenue targets, and expanding market share while building strong customer relationships. Working in a collaborative environment, you'll leverage our industry-leading technologies and solutions to help customers make breakthrough discoveries and improve lives globally. As a commercial leader, you'll develop and execute strategic sales plans, support and coach sales professionals, and collaborate across divisions to deliver exceptional customer value. You'll drive business growth through market analysis, pipeline management, and cross-functional partnerships while maintaining the highest standards of integrity and customer focus.</p><p>Role purpose</p><p>Own and accelerate the Saudi Arabia commercial agenda. The Commercial Lead will translate market potential into profitable growth, strategic access, stronger customer positions, and disciplined execution across diagnostics markets.</p><p>Core accountabilities</p><p>Set the country strategy</p><p>Define where to play, how to win, and where not to invest in collaboration with MEA SDG Leadership</p><p>Align the Saudi growth agenda with Vision 2030, healthcare transformation, localization, and biotechnology strategy.</p><p>Convert market insight into a focused three-year commercial plan.</p><p>Deliver profitable growth</p><p>Own revenue, margin, forecast accuracy, pipeline quality, pricing, and market share.</p><p>Drive growth across priority portfolios.</p><p>Balance short-term delivery with long-term market creation.</p><p>Eliminate low-quality revenue, uncontrolled discounting, and weak commercial discipline.</p><p>Build strategic markets</p><p>Develop emerging opportunities across all portfolios</p><p>Build adoption pathways with clinicians, laboratories, hospitals &amp; government.</p><p>Turn clinical and scientific value into scalable commercial models.</p><p>Lead strategic accounts</p><p>Own executive relationships with major public and private customers.</p><p>Build account plans around decision-makers, budgets, tenders, competitive position, and expansion opportunities.</p><p>Lead the most complex and strategically important deals personally.</p><p>Move customer relationships from transactional to long term.</p><p>Shape government and market access</p><p>Build trusted relationships across ministries, public healthcare systems, regulators, sovereign-backed entities, and national programmes.</p><p>Anticipate policy, reimbursement, procurement, localization, and regulatory changes.</p><p>Convert national priorities into commercial opportunities while maintaining the highest standards of compliance.</p><p>Control channels and execution</p><p>Design the right direct and indirect route-to-market model.</p><p>Set hard performance expectations for distributors and partners.</p><p>Improve visibility, inventory discipline, customer coverage, service quality, and forecast accuracy.</p><p>Replace weak execution with clear accountability.</p><p>Build a high-performance organization</p><p>Lead, coach, and strengthen the Saudi commercial team.</p><p>Create a culture of ownership, pace, evidence, and follow-through.</p><p>Address underperformance directly.</p><p>Mobilize cross-functional teams around country priorities.</p><p>Leadership expectations</p><p>The Commercial Lead must:</p><p>Make hard choices with imperfect information.</p><p>Challenge inflated assumptions and false precision.</p><p>Operate credibly with government, clinicians, scientists, procurement, and executives.</p><p>Move quickly without sacrificing judgement, margin, or compliance.</p><p>Turn strategy into execution and execution into results.</p><p>Required experience</p><p>Strong commercial leadership experience in Saudi Arabia or the Gulf.</p><p>Proven ownership of a significant revenue target, P&amp;L, or country operation.</p><p>Relevant experience in diagnostics, life sciences, healthcare, pharmaceuticals &amp; medical devices.</p><p>Strong government, strategic-account, tender, and channel-management experience.</p><p>Demonstrated success in building markets and delivering profitable growth.</p><p>Strong commercial, financial, and analytical judgement.</p><p>English required; Arabic strongly preferred.</p><p>Measures of success</p><p>Revenue and margin growth</p><p>Market-share gain</p><p>Strategic account expansion</p><p>Pipeline quality and conversion</p><p>Forecast accuracy</p><p>Pricing discipline</p><p>New-market creation</p><p>Channel performance</p><p>Customer retention</p><p>Team capability</p><p>Compliance and execution quality</p><p>First-year mandate</p><p>Within 12 months, the Commercial Lead will:</p><p>Establish a rigorous Saudi market and portfolio strategy.</p><p>Prioritize the highest-value growth opportunities.</p><p>Strengthen strategic-account and government engagement.</p><p>Improve pipeline, forecast, pricing, and tender discipline.</p><p>Upgrade channel performance.</p><p>Build growth plans for priority diagnostic and life-science markets.</p><p>Strengthen team capability and accountability.</p><p>Deliver visible commercial wins.</p><p><br></p><p><strong>Desired Candidate Profile</strong></p><p>Strong commercial leadership experience in Saudi Arabia or the Gulf. Proven ownership of a significant revenue target, P&amp;L, or country operation. Relevant experience in diagnostics, life sciences, healthcare, pharmaceuticals &amp; medical devices. Strong government, strategic-account, tender, and channel-management experience. Demonstrated success in building markets and delivering profitable growth. Strong commercial, financial, and analytical judgement. English required; Arabic strongly preferred.</p>

<h2 class="h5">Job description</h2> <div class="t-break" data-jb-field="description"> <p><b>Work Schedule</b></p><br>Standard (Mon-Fri)<p><b>Environmental Conditions</b></p><br>Office<p><b><u>Job Description</u></b></p><br><p>As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.</p><br><p>DESCRIPTION:<br>Join our team as a Senior Sales Manager at Thermo Fisher Scientific, where you'll guide and develop commercial teams to drive strategic growth across our innovative portfolio. You'll be responsible for implementing effective sales strategies, achieving revenue targets, and expanding market share while building strong customer relationships. Working in a collaborative environment, you'll leverage our industry-leading technologies and solutions to help customers make breakthrough discoveries and improve lives globally.<br>As a commercial leader, you'll develop and execute strategic sales plans, support and coach sales professionals, and collaborate across divisions to deliver exceptional customer value. You'll drive business growth through market analysis, pipeline management, and cross-functional partnerships while maintaining the highest standards of integrity and customer focus.</p><br><p><b>Role purpose</b></p><br><p>Own and accelerate the Saudi Arabia commercial agenda.</p><br><p>The Commercial Lead will translate market potential into profitable growth, strategic access, stronger customer positions, and disciplined execution across diagnostics markets.</p><br><p><b>Core accountabilities</b></p><br><p><b>Set the country strategy</b></p><br><ul><li>Define where to play, how to win, and where not to invest in collaboration with MEA SDG Leadership&nbsp;</li><li>Align the Saudi growth agenda with Vision 2030, healthcare transformation, localization, and biotechnology strategy.</li><li>Convert market insight into a focused three-year commercial plan.</li></ul><p><b>Deliver profitable growth</b></p><br><ul><li>Own revenue, margin, forecast accuracy, pipeline quality, pricing, and market share.</li><li>Drive growth across priority portfolios.</li><li>Balance short-term delivery with long-term market creation.</li><li>Eliminate low-quality revenue, uncontrolled discounting, and weak commercial discipline.</li></ul><p><b>Build strategic markets</b></p><br><ul><li>Develop emerging opportunities across all portfolios</li><li>Build adoption pathways with clinicians, laboratories, hospitals &amp; government.</li><li>Turn clinical and scientific value into scalable commercial models.</li></ul><p><b>Lead strategic accounts</b></p><br><ul><li>Own executive relationships with major public and private customers.</li><li>Build account plans around decision-makers, budgets, tenders, competitive position, and expansion opportunities.</li><li>Lead the most complex and strategically important deals personally.</li><li>Move customer relationships from transactional to long term.</li></ul><p><b>Shape government and market access</b></p><br><ul><li>Build trusted relationships across ministries, public healthcare systems, regulators, sovereign-backed entities, and national programmes.</li><li>Anticipate policy, reimbursement, procurement, localization, and regulatory changes.</li><li>Convert national priorities into commercial opportunities while maintaining the highest standards of compliance.</li></ul><p><b>Control channels and execution</b></p><br><ul><li>Design the right direct and indirect route-to-market model.</li><li>Set hard performance expectations for distributors and partners.</li><li>Improve visibility, inventory discipline, customer coverage, service quality, and forecast accuracy.</li><li>Replace weak execution with clear accountability.</li></ul><p><b>Build a high-performance organization</b></p><br><ul><li>Lead, coach, and strengthen the Saudi commercial team.</li><li>Create a culture of ownership, pace, evidence, and follow-through.</li><li>Address underperformance directly.</li><li>Mobilize cross-functional teams around country priorities.</li></ul><p><b>Leadership expectations</b></p><br><p>The Commercial Lead must:</p><br><ul><li>Make hard choices with imperfect information.</li><li>Challenge inflated assumptions and false precision.</li><li>Operate credibly with government, clinicians, scientists, procurement, and executives.</li><li>Move quickly without sacrificing judgement, margin, or compliance.</li><li>Turn strategy into execution and execution into results.</li></ul><p><b>Required experience</b></p><br><ul><li>Strong commercial leadership experience in Saudi Arabia or the Gulf.</li><li>Proven ownership of a significant revenue target, P&amp;L, or country operation.</li><li>Relevant experience in diagnostics, life sciences, healthcare, pharmaceuticals &amp; medical devices.</li><li>Strong government, strategic-account, tender, and channel-management experience.</li><li>Demonstrated success in building markets and delivering profitable growth.</li><li>Strong commercial, financial, and analytical judgement.</li><li>English required; Arabic strongly preferred.</li></ul><p><b>Measures of success</b></p><br><ul><li>Revenue and margin growth</li><li>Market-share gain</li><li>Strategic account expansion</li><li>Pipeline quality and conversion</li><li>Forecast accuracy</li><li>Pricing discipline</li><li>New-market creation</li><li>Channel performance</li><li>Customer retention</li><li>Team capability</li><li>Compliance and execution quality</li></ul><p><b>First-year mandate</b></p><br><p>Within 12 months, the Commercial Lead will:</p><br><p>Establish a rigorous Saudi market and portfolio strategy. Prioritize the highest-value growth opportunities. Strengthen strategic-account and government engagement. Improve pipeline, forecast, pricing, and tender discipline. Upgrade channel performance. Build growth plans for priority diagnostic and life-science markets. Strengthen team capability and accountability. Deliver visible commercial wins.</p><br><p><b>Leadership profile</b></p><br><p>A strategic operator with the pace to build, the judgement to prioritize, and the discipline to deliver.</p><br><p>This role is for someone who creates clarity, raises standards, and owns the outcome.</p><br> </div><h2 data-automation-id="subHeaderPreferredCandidate" class="h5"> Preferred candidate </h2> <div class="row is-m v-align-top t-small bg-mute"> <div class="col is-3 p5" data-automation-id="label_Years_of_experience"> <b>Years of experience</b> </div> <div class="col is-9 p5" data-automation-id="data_Years_of_experience"> 5+ years </div> </div> <div class="row is-m v-align-top t-small "> <div class="col is-3 p5" data-automation-id="label_Degree"> <b>Degree</b> </div> <div class="col is-9 p5" data-automation-id="data_Degree"> Bachelor's degree / higher diploma </div> </div>

<h2 class="h5">Job description</h2> <div class="t-break" data-jb-field="description"> <p><b>Work Schedule</b></p><br>Standard Office Hours (40/wk)<p><b>Environmental Conditions</b></p><br>Office<p><b><u>Job Description</u></b></p><br><p>As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.<br>DESCRIPTION:</p><br><p><span>SIOP Manage </span>is responsible for leading the end-to-end Sales, Inventory, and Operations Planning (SIOP) process for a Thermo Fisher–aligned portfolio within a complex life sciences, diagnostics, laboratory products, or regulated manufacturing environment. This role will drive cross-functional alignment across Commercial, Operations, Procurement, Finance, Quality, and Product Management to develop and maintain a consensus-based operating plan that supports customer service, revenue, inventory, and margin objectives.</p><br><p>The incumbent will own monthly SIOP governance, facilitate decision-making on demand and supply imbalances, manage inventory strategies across the portfolio, and provide executive-level visibility to risks, opportunities, and mitigation actions. The role requires strong analytical capability, business acumen, and the ability to influence in a matrixed organization.</p><br>Essential Duties and Responsibilities<ul><li>Lead the monthly SIOP process, including demand review, supply review, inventory review, pre-SIOP, and executive SIOP meetings.</li><li>Partner with Commercial and Product Management teams to translate market intelligence, sales pipeline inputs, promotion plans, installed-base demand, lifecycle events, and regional requirements into a consensus demand plan.</li><li>Collaborate with Supply Planning, Manufacturing, and Distribution to ensure capacity, material availability, and fulfillment strategies support business priorities.</li><li>Establish and manage inventory strategies across finished goods, spare parts and critical consumables and components to balance service levels, shelf-life constraints, working capital, and obsolescence risk.</li><li>Identify and resolve demand-supply gaps through scenario planning, prioritization, and cross-functional decision-making.</li><li>Lead risk assessments and mitigation planning related to supplier constraints, quality events, regulatory changes, product transitions, allocation decisions, and logistics disruptions.</li><li>Present recommendations, trade-offs, and performance updates to senior leadership during executive SIOP reviews.</li><li>Support new product introduction (NPI), product phase-in / phase-out, end-of-life planning, and engineering or regulatory change impacts within the portfolio.</li><li>Ensure planning assumptions, master data, and key inputs are accurate, documented, and aligned across systems and stakeholders.</li><li>Monitor and report key performance indicators, including forecast accuracy, inventory turns, days of supply, service level, backorder, plan adherence, excess and obsolete inventory, and capacity utilization.</li><li>Drive continuous improvement initiatives to improve planning discipline, planning system usage, process efficiency, and portfolio performance.</li><li>Serve as the primary cross-functional point of contact for portfolio-level planning decisions and escalations.</li></ul>Scope and Portfolio Considerations<p>This role supports a product portfolio aligned to the Thermo Fisher operating environment and may include:</p><br><ul><li>laboratory instruments and consumables</li><li>analytical and chromatography products</li><li>biosciences, reagents, and chemicals</li><li>diagnostic or clinical product lines</li><li>regulated consumables and aftermarket/service demand</li></ul><p>Planning complexity may include:</p><br><ul><li>high SKU and product family complexity</li><li>global manufacturing and supplier networks</li><li>regulated quality and compliance requirements</li><li>expiration-sensitive or shelf-life constrained inventory</li><li>cold chain, hazardous materials, or controlled distribution considerations</li><li>long-lead or sole-source components</li><li>product lifecycle transitions and innovation pipelines</li><li>installed-base and service-driven replenishment demand</li></ul>Required Qualifications<ul><li>Bachelor’s degree in Supply Chain, Operations Management, Industrial Engineering, Business Administration, Finance, or related field.</li><li>7–10 years of relevant experience in SIOP, S&amp;OP, integrated business planning, demand planning, supply planning, inventory planning, or related supply chain functions.</li><li>Experience in life sciences, diagnostics, medical devices, laboratory products, specialty chemicals, or another regulated and operationally complex industry.</li><li>Demonstrated experience leading cross-functional planning processes and driving consensus across matrixed teams.</li><li>Strong understanding of demand planning, inventory optimization, supply planning, capacity planning, and business trade-off management.</li><li>Experience analyzing and presenting planning data, risks, and recommendations to senior leadership.</li><li>Proficiency in ERP and planning systems, as well as advanced Excel and reporting tools.</li></ul>Preferred Qualifications<ul><li>Prior experience supporting a Thermo Fisher Scientific portfolio or a similar life sciences / laboratory products environment.</li><li>APICS / ASCM certification such as CPIM, CSCP, or CLTD.</li><li>MBA or other advanced degree.</li><li>Experience with SAP, Oracle, Power BI, Tableau, or equivalent planning and analytics tools.</li><li>Knowledge of GMP, FDA, ISO, or other regulated operational frameworks.</li><li>Experience with instrument and consumable demand linkage, distributor demand patterns, and global portfolio planning.</li></ul>Knowledge, Skills, and Abilities<ul><li>Strong facilitation and stakeholder management skills.</li><li>Excellent analytical, quantitative, and problem-solving abilities.</li><li>Ability to synthesize large data sets into clear business recommendations.</li><li>Strong verbal and written communication skills, including executive-level presentations.</li><li>Ability to manage competing priorities and make decisions in ambiguous or rapidly changing environments.</li><li>Strong understanding of inventory and working capital drivers.</li><li>High level of business partnership and ability to influence without direct authority.</li><li>Continuous improvement mindset with strong process discipline.</li></ul>Key Performance Indicators<ul><li>Forecast accuracy and forecast bias</li><li>Service level / OTIF performance</li><li>Inventory turns and days of supply</li><li>Backorder and past-due order reduction</li><li>Excess and obsolete inventory reduction</li><li>Capacity visibility and plan adherence</li><li>SIOP calendar compliance and action closure</li><li>Revenue support and customer service during constrained supply periods</li></ul> </div><h2 data-automation-id="subHeaderPreferredCandidate" class="h5"> Preferred candidate </h2> <div class="row is-m v-align-top t-small bg-mute"> <div class="col is-3 p5" data-automation-id="label_Years_of_experience"> <b>Years of experience</b> </div> <div class="col is-9 p5" data-automation-id="data_Years_of_experience"> No experience required </div> </div> <div class="row is-m v-align-top t-small "> <div class="col is-3 p5" data-automation-id="label_Degree"> <b>Degree</b> </div> <div class="col is-9 p5" data-automation-id="data_Degree"> Bachelor's degree / higher diploma </div> </div>

<p> <b>Work Schedule</b> </p>Standard (Mon-Fri)<p> </p> <p> <b>Environmental Conditions</b> </p>Office<p> </p> <p> <b> <u>Job Description</u> </b> </p> <p> </p> <p>Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation<br>The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs. This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy.</p> <p> <br> <br> <b><br>What You'll Do:</b><br> Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.<br> Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.<br> Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.<br> Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.<br> May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.<br> May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.<br> May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.<br> <br><b>Education &amp; Experience Requirements:<br></b> Bachelor's degree or equivalent and relevant formal academic / vocational qualification<br> Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).<br> <br>In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.<br> <br>Knowledge, Skills, Abilities:<br> Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams<br> Good planning and organizational skills to enable effective prioritization of workload<br> Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization<br> Capable of working effectively in a changing environment with complex/ambiguous situations<br> Familiarity with the practices, processes, and requirements of clinical monitoring<br> Good judgment and decision making skills<br> Effective oral and written communication skills, including English language proficiency<br> Capable of evaluating workload against project budget and adjusting resources accordingly<br> Sound financial acument and knowledge of budgeting, forecasting and fiscal management<br> Strong attention to detail<br> Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.<br> Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.<br> <br>Working Conditions and Environment:<br> Work is performed in an office environment with exposure to electrical office equipment.<br> Frequently drives to site locations and frequently travels both domestic and international.<br> <br>Why Join Us?<br> <br>When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You ll work in an environment where collaboration and development are part of the everyday experience and where your contributions truly make a difference.<br> <br>Apply today to help us deliver tomorrow s breakthroughs.</p> <p> </p> <p> </p> <p> </p> <p> </p>

<h3 style="font-size:18px; font-weight:700; margin:16px 0 8px;">About the Role</h3> <p style="margin:0 0 12px; ************;">Thermo Fisher Scientific, Inc. is seeking a Clinical Operations Manager for its FSP (Functional Service Provider) division in Saudi Arabia. This full-time position involves overseeing clinical operations teams to support pharmaceutical and biotechnology companies in managing global clinical trials.</p> <h3 style="font-size:18px; font-weight:700; margin:16px 0 8px;">Role Overview and Responsibilities</h3> <p style="margin:0 0 12px; ************;">The Clinical Operations Manager will be responsible for the direct management of clinical operations staff. This includes providing oversight, training, resource allocation, coaching, and performance management to ensure the achievement of end results measured by key performance indicators. The role serves as a point of escalation for performance and training concerns, ensuring adherence to company Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs). Collaboration with the leadership team for resourcing needs is also a critical component of this position.</p> <ul style="margin:0 0 12px; padding-inline-start:24px; list-style-type:disc; list-style-position:outside;"> <li style="margin:0 0 6px;">Manage staff, providing coaching, mentorship, and work direction.</li> <li style="margin:0 0 6px;">Conduct regular performance appraisals and career discussions to facilitate employee development.</li> <li style="margin:0 0 6px;">Oversee the recruitment, interview, and selection process for new staff.</li> <li style="margin:0 0 6px;">Manage and conduct induction and orientation programs for new employees.</li> <li style="margin:0 0 6px;">Ensure all staff CVs, training records, position profiles, and experience profiles are complete and current.</li> <li style="margin:0 0 6px;">Monitor and ensure the timeliness and accuracy of timesheets and expense reports.</li> <li style="margin:0 0 6px;">Support staff allocation activities according to local resourcing processes and optimize project operations.</li> <li style="margin:0 0 6px;">Identify and raise any issues that may impact project deliverables.</li> <li style="margin:0 0 6px;">Deliver training on Working Practice Documents (WPDs), Standard Operating Procedures (SOPs), local requirements, and other relevant clinical operations topics.</li> <li style="margin:0 0 6px;">Identify training gaps and ensure all training requirements are met.</li> <li style="margin:0 0 6px;">Assure adherence to good ethical and regulatory standards.</li> <li style="margin:0 0 6px;">Alert management to quality issues, request QA audits, and facilitate client and internal quality assurance audits.</li> <li style="margin:0 0 6px;">Review systems (*, Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs, and overall project status.</li> <li style="margin:0 0 6px;">Evaluate staff work, including conducting PAVs (remote or on-site) to assess monitoring skills and project execution.</li> <li style="margin:0 0 6px;">Participate in process improvement and development initiatives.</li> <li style="margin:0 0 6px;">Ensure understanding and facilitation of the risk-based monitoring approach.</li> <li style="margin:0 0 6px;">Provide input into bids and contribute to business development efforts.</li> <li style="margin:0 0 6px;">Collaborate with senior management on strategic planning and business development.</li> <li style="margin:0 0 6px;">Lead or contribute to initiatives aimed at enhancing department performance or driving process improvements across the company.</li> </ul> <h3 style="font-size:18px; font-weight:700; margin:16px 0 8px;">Qualifications and Experience</h3> <p style="margin:0 0 12px; ************;">Candidates should possess the knowledge, skills, and abilities required for the role, typically equivalent to 5 or more years of relevant experience. A minimum of 1 year of leadership responsibility is required, along with advanced mentoring, leadership, and supervisory skills. Demonstrated excellent clinical trials monitoring skills, both remote and on-site, are essential. Candidates must have a demonstrated understanding of, or the ability to quickly learn, the company’s SOPs, WPDs, and relevant regulations such as ICH/GCP and FDA guidelines. The ability to evaluate medical research data is also required.</p> <ul style="margin:0 0 12px; padding-inline-start:24px; list-style-type:disc; list-style-position:outside;"> <li style="margin:0 0 6px;">5+ years of relevant experience.</li> <li style="margin:0 0 6px;">1+ year of leadership responsibility.</li> <li style="margin:0 0 6px;">Advanced mentoring/leadership/supervisory skills.</li> <li style="margin:0 0 6px;">Excellent clinical trials monitoring skills (Remote and on-site).</li> <li style="margin:0 0 6px;">Demonstrated understanding of or ability to learn company SOPs, WPDs, and relevant regulations (*, ICH/GCP, FDA guidelines).</li> <li style="margin:0 0 6px;">Demonstrated ability to evaluate medical research data.</li> <li style="margin:0 0 6px;">Solid knowledge of medical/therapeutic areas and medical terminology.</li> </ul> <h3 style="font-size:18px; font-weight:700; margin:16px 0 8px;">Required Skills and Competencies</h3> <p style="margin:0 0 12px; ************;">Strong organizational and negotiation skills are necessary, as is a high level of attention to detail. Advanced written and oral communication skills are required. Fluency in Arabic and a very good command of English language and grammar are essential for this role. Candidates must demonstrate proficiency in using computers for data entry, archival, and retrieval. The ability to travel as needed is also a requirement.</p> <ul style="margin:0 0 12px; padding-inline-start:24px; list-style-type:disc; list-style-position:outside;"> <li style="margin:0 0 6px;">Strong organizational and negotiation skills.</li> <li style="margin:0 0 6px;">Strong attention to detail.</li> <li style="margin:0 0 6px;">Advanced written and oral communication skills.</li> <li style="margin:0 0 6px;">Fluency in Arabic and very good knowledge of English language and grammar.</li> <li style="margin:0 0 6px;">Demonstrated use of computer for data entry, archival, and retrieval.</li> <li style="margin:0 0 6px;">Ability to travel as needed.</li> <li style="margin:0 0 6px;">Excellent teammate with team building skills.</li> <li style="margin:0 0 6px;">Excellent interpersonal and conflict resolution skills.</li> <li style="margin:0 0 6px;">Advanced ability to utilize problem-solving techniques applicable to a constantly changing environment.</li> </ul> <h3 style="font-size:18px; font-weight:700; margin:16px 0 8px;">Work Type and Considerations</h3> <p style="margin:0 0 12px; ************;">This is a full-time position. In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.</p>

<h3 style="font-size:18px; font-weight:700; margin:16px 0 8px;">About the Clinical Research Associate Role</h3> <p style="margin:0 0 12px; ************;">Thermo Fisher Scientific, Inc. is seeking a Clinical Research Associate (CRA) I/II to join their FSP team. This is a full-time position. In this role, you will be responsible for coordinating and executing all aspects of clinical monitoring and site management processes across various sponsors and monitoring environments. You will act as a specialist in site processes, ensuring trials adhere to approved protocols, ICH-GCP guidelines, applicable regulations, and Standard Operating Procedures (SOPs) to safeguard subject rights, well-being, and data integrity. The role requires a proactive approach to ensure audit readiness and foster collaborative relationships with investigational sites.</p> <h3 style="font-size:18px; font-weight:700; margin:16px 0 8px;">Key Responsibilities</h3> <ul style="margin:0 0 12px; padding-inline-start:24px; list-style-type:disc; list-style-position:outside;"> <li style="margin:0 0 6px;">Conduct site monitoring using a risk-based approach, applying root cause analysis and critical thinking to identify and resolve process failures and mitigate risks.</li> <li style="margin:0 0 6px;">Ensure data accuracy through Source Data Review (SDR) and Source Data Verification (SDV) via on-site and remote monitoring.</li> <li style="margin:0 0 6px;">Assess investigational products through physical inventory checks and record reviews.</li> <li style="margin:0 0 6px;">Document observations and findings in reports and letters according to approved business writing standards.</li> <li style="margin:0 0 6px;">Expeditiously escalate observed deficiencies and issues to clinical management and follow them through to resolution.</li> <li style="margin:0 0 6px;">Maintain regular contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording.</li> <li style="margin:0 0 6px;">Execute monitoring tasks in accordance with the approved monitoring plan.</li> <li style="margin:0 0 6px;">Participate in the investigator payment process.</li> <li style="margin:0 0 6px;">Collaborate with project team members on issue and finding resolution.</li> <li style="margin:0 0 6px;">Investigate and follow up on findings as applicable.</li> <li style="margin:0 0 6px;">Participate in investigator meetings as required.</li> <li style="margin:0 0 6px;">Identify potential investigators in collaboration with the client to ensure site acceptability.</li> <li style="margin:0 0 6px;">Initiate clinical trial sites in compliance with relevant procedures, protocol, and regulatory obligations, making recommendations as needed.</li> <li style="margin:0 0 6px;">Perform trial close-out activities and retrieve trial materials.</li> <li style="margin:0 0 6px;">Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations.</li> <li style="margin:0 0 6px;">Conduct on-site file reviews as per project specifications.</li> <li style="margin:0 0 6px;">Provide trial status tracking and progress reports to the Clinical Team Manager (CTM).</li> <li style="margin:0 0 6px;">Ensure study systems, such as the Clinical Trial Management System (CTMS), are updated according to study conventions.</li> <li style="margin:0 0 6px;">Facilitate effective communication between investigative sites, the client, and the project team.</li> <li style="margin:0 0 6px;">Respond to company, client, and regulatory requirements, audits, and inspections.</li> <li style="margin:0 0 6px;">Complete administrative tasks, including expense reports and timesheets, in a timely manner.</li> <li style="margin:0 0 6px;">Contribute to the project team by assisting in the preparation of project publications/tools and sharing ideas for process improvement.</li> </ul> <h3 style="font-size:18px; font-weight:700; margin:16px 0 8px;">Qualifications and Experience</h3> <p style="margin:0 0 12px; ************;">Candidates should possess a Bachelor's degree in a life science-related field, or a Registered Nursing certification, or an equivalent relevant academic or vocational qualification. A valid driver's license is required where applicable. The role requires 0-1 years of experience. Proven clinical monitoring skills are essential, along with a demonstrated understanding of medical/therapeutic area knowledge and medical terminology.</p> <h3 style="font-size:18px; font-weight:700; margin:16px 0 8px;">Required Skills and Competencies</h3> <ul style="margin:0 0 12px; padding-inline-start:24px; list-style-type:disc; list-style-position:outside;"> <li style="margin:0 0 6px;">Demonstrated ability to attain and maintain working knowledge of ICH GCPs, applicable regulations, and procedural documents.</li> <li style="margin:0 0 6px;">Well-developed critical thinking skills, including a critical mindset, in-depth investigation for root cause analysis, and problem-solving abilities.</li> <li style="margin:0 0 6px;">Ability to manage Risk-Based Monitoring concepts and processes.</li> <li style="margin:0 0 6px;">Good oral and written communication skills, with the ability to communicate effectively with medical personnel.</li> <li style="margin:0 0 6px;">Ability to maintain customer focus through effective listening, attention to detail, and identifying underlying customer issues.</li> <li style="margin:0 0 6px;">Good organizational and time management skills.</li> <li style="margin:0 0 6px;">Effective interpersonal skills.</li> <li style="margin:0 0 6px;">Attention to detail.</li> <li style="margin:0 0 6px;">Ability to remain flexible and adaptable in various scenarios.</li> <li style="margin:0 0 6px;">Ability to work independently or as part of a team.</li> <li style="margin:0 0 6px;">Good computer skills, including solid knowledge of Microsoft Office and the ability to learn new software.</li> <li style="margin:0 0 6px;">Good English language and grammar skills.</li> <li style="margin:0 0 6px;">Good presentation skills.</li> </ul> <h3 style="font-size:18px; font-weight:700; margin:16px 0 8px;">Work Environment and Travel</h3> <p style="margin:0 0 12px; ************;">Work may be performed in an office, laboratory, clinical, or home office environment. This role involves frequent travel to site locations, generally estimated at 60-80%, with potential for extended overnight stays. Exposure to electrical office equipment is expected. There may be exposure to biological fluids with potential for infectious organisms, requiring the use of personal protective equipment such as protective eyewear, garments, and gloves. Occasional exposure to fluctuating or extreme temperatures may occur.</p>

<h2 class="h5">Job description</h2> <div class="t-break" data-jb-field="description"> <p><b>Work Schedule</b></p><br>Standard (Mon-Fri)<p><b>Environmental Conditions</b></p><br>Office<p><b><u>Job Description</u></b></p><br><p>Join Us as Clinical Operations Manager – Make an Impact at the Forefront of Innovation<br>We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.<br>As a Clinical Operations Manager , you will oversee, train, resource, coach and performance manage a team, which may be inclusive of various clinical operations focused staff. You will focus on end results using metrics and key performance indicators to lead performance. You will act as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. You will also work in collaboration with the leadership team for resourcing needs.<br>What You’ll Do:<br>• Manages staff, providing coaching, mentorship and work direction.<br>• Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff.<br>• Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.<br>• Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports.<br>• Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Raises appropriately any issues which may impact project deliverables.<br>• Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.<br>• Assures adherence to good ethical and regulatory standards.<br>• Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required.<br>• Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.<br>• Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.<br>• Participates in process improvement/development initiatives.<br>• Ensures understanding and facilitation of the risk-based monitoring approach.<br>• May provide input into bids and contribute to the procurement of new business where required.<br>• Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required.<br>• May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.<br>Education and Experience Requirements:<br>• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).<br>• 1+ year of leadership responsibility<br>In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.<br>Knowledge, Skills and Abilities:<br>• Advanced mentoring/leadership/supervisory skills<br>• Excellent clinical trials monitoring skills; Remote and on-site<br>• Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)<br>• Demonstrated ability to evaluate medical research data<br>• Strong organizational and negotiation skills<br>• Strong attention to detail<br>• Advanced written and oral communication skills<br>• Fluency in Arabic and very good knowledge of English language and grammar<br>• Demonstrated use of computer to include data entry, archival and retrieval<br>• Ability to travel as needed<br>• Excellent teammate with team building skills<br>• Excellent interpersonal and conflict resolution skills<br>• Advanced ability to utilize problem-solving techniques applicable to constantly changing environment<br>• Solid knowledge of medical/therapeutic areas and medical terminology<br>Why Join Us?<br>When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.<br>Apply today to help us deliver tomorrow’s breakthroughs.</p><br> </div><h2 data-automation-id="subHeaderPreferredCandidate" class="h5"> Preferred candidate </h2> <div class="row is-m v-align-top t-small bg-mute"> <div class="col is-3 p5" data-automation-id="label_Years_of_experience"> <b>Years of experience</b> </div> <div class="col is-9 p5" data-automation-id="data_Years_of_experience"> 5+ years </div> </div> <div class="row is-m v-align-top t-small "> <div class="col is-3 p5" data-automation-id="label_Degree"> <b>Degree</b> </div> <div class="col is-9 p5" data-automation-id="data_Degree"> Bachelor's degree / higher diploma </div> </div>

<h2 class="h5">Job description</h2> <div class="t-break" data-jb-field="description"> <p><b>Work Schedule</b></p><br>Standard (Mon-Fri)<p><b>Environmental Conditions</b></p><br>Office<p><b><u>Job Description</u></b></p><br><p>Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation<br>We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.<br>As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.<br>What You’ll Do:<br>• Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.<br>• Provides, under guidance local regulatory strategy advice (MoH &amp;/or EC) to internal clients.<br>• Provides project specific local SIA services and coordination of these projects.<br>• May have contact with investigators for submission related activities.<br>• Key-contact at country level for either Ethical or Regulatory submission-related activities.<br>• Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.<br>• Achieves PPD’s target cycle times for site.<br>• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.<br>• May develop country specific Patient Information Sheet/Informed Consent form documents.<br>• May assist with grant budgets(s) and payment schedules negotiations with sites.<br>• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.<br>• Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.<br>• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.<br>• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.<br>Education and Experience Requirements:<br>• Bachelor's degree or equivalent and relevant formal academic / vocational qualification<br>• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).<br>In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.<br>Knowledge, Skills and Abilities:<br>• Effective oral and written communication skills<br>• Excellent interpersonal skills<br>• Strong attention to detail and quality of documentation<br>• Good negotiation skills<br>• Good computer skills and the ability to learn appropriate software<br>• Good English language and grammar skills<br>• Basic medical/therapeutic area and medical terminology knowledge<br>• Ability to work in a team environment or independently, under direction, as required<br>• Basic organizational and planning skills<br>• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations<br>Working Conditions and Environment:<br>• Work is performed in an office/ laboratory and/or a clinical environment.<br>• Exposure to biological fluids with potential exposure to infectious organisms.<br>• Exposure to electrical office equipment.<br>• Personal protective equipment required such as protective eyewear, garments and gloves</p><br> </div><h2 data-automation-id="subHeaderPreferredCandidate" class="h5"> Preferred candidate </h2> <div class="row is-m v-align-top t-small bg-mute"> <div class="col is-3 p5" data-automation-id="label_Years_of_experience"> <b>Years of experience</b> </div> <div class="col is-9 p5" data-automation-id="data_Years_of_experience"> No experience required </div> </div> <div class="row is-m v-align-top t-small "> <div class="col is-3 p5" data-automation-id="label_Degree"> <b>Degree</b> </div> <div class="col is-9 p5" data-automation-id="data_Degree"> Bachelor's degree / higher diploma </div> </div>

<h2 class="h5">Job description</h2> <div class="t-break" data-jb-field="description"> <p><b>Work Schedule</b></p><br>Standard (Mon-Fri)<p><b>Environmental Conditions</b></p><br>Office<p><b><u>Job Description</u></b></p><br><p><span>At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future</span></p><br><p>Our team is expanding, and we are looking to recruit a Contract Specialist or Senior Contract Specialist for our growing FSP environment.</p><br><ul><li><p>The Contract Specialist in the FSP group is responsible for managing and overseeing contractual aspects of clinical trials conducted by the FSP on behalf of its clients. This role involves negotiating, drafting, and finalizing high-value and complex contracts, ensuring compliance with relevant regulations, and maintaining effective communication with internal and external stakeholders. The Senior Contract Specialist also provides mentorship and guidance to junior contract specialists.<br>&nbsp;</p><br><p><b>Key Responsibilities:</b></p><br><ul><li>Draft, review, and negotiate high-value and complex contracts related to clinical trials, including Clinical Trial Agreements (CTAs), Confidentiality Agreements (CDAs), and other relevant documents.</li><li>Ensure contracts are compliant with local and international regulations and company policies.</li><li>Collaborate with internal teams, including legal, clinical operations, regulatory affairs, and finance, to ensure alignment and compliance with contractual requirements.</li><li>Liaise with external stakeholders, including clients, sites, and vendors, to facilitate the contract negotiation and approval process.</li><li>Monitor the progress of contract negotiations and address any issues or concerns that arise.</li><li>Maintain accurate records and documentation related to contracts and agreements.</li><li>Provide guidance and support to project teams on contractual matters throughout the lifecycle of clinical trials.</li><li>Participate in the development and implementation of contract management strategies and processes.</li><li>Ensure timely execution of contracts to meet project timelines and deadlines.</li><li>Support the resolution of contractual disputes and issues as they arise.</li><li>Stay up-to-date with changes in regulations and industry standards related to clinical trial contracts.</li><li>Mentor and provide guidance to junior contract specialists, assisting in their professional development.</li><li>Participate in training sessions and workshops to enhance the contract management skills of the team.<br>&nbsp;</li></ul><p><b>Qualifications:</b></p><br><ul><li>Bachelor’s degree in a relevant field (e.g., Law, Business Administration, Life Sciences).</li><li>Extensive experience in contract management or negotiation within the pharmaceutical, clinical research, or related industry.</li><li>Strong knowledge of contractual regulations and guidelines governing clinical trials.</li><li>Excellent organizational and project management skills.</li><li>Effective communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams.</li><li>Attention to detail and the ability to manage multiple projects and deadlines.</li><li>Proficiency in both written and spoken English; additional language skills may be beneficial depending on the location.<br>&nbsp;</li></ul><p><b>Preferred Qualifications:</b></p><br><ul><li>Advanced degree or certification in contract management or a related field.</li><li>Experience in an FSP environment, providing services to multiple clients.</li><li>Familiarity with electronic contract management systems and databases.</li><li>Previous experience in a senior or leadership role within contract management.</li></ul><br><br><br><br></li></ul> </div><h2 data-automation-id="subHeaderPreferredCandidate" class="h5"> Preferred candidate </h2> <div class="row is-m v-align-top t-small bg-mute"> <div class="col is-3 p5" data-automation-id="label_Years_of_experience"> <b>Years of experience</b> </div> <div class="col is-9 p5" data-automation-id="data_Years_of_experience"> No experience required </div> </div> <div class="row is-m v-align-top t-small "> <div class="col is-3 p5" data-automation-id="label_Degree"> <b>Degree</b> </div> <div class="col is-9 p5" data-automation-id="data_Degree"> Bachelor's degree / higher diploma </div> </div>

<h2 class="h5">Job description</h2> <div class="t-break" data-jb-field="description"> <p><b>Work Schedule</b></p><br>Standard (Mon-Fri)<p><b>Environmental Conditions</b></p><br>Office<p><b><u>Job Description</u></b></p><br><p>Join Us as a Clinical Research Associate (Level I/II) – Make an Impact at the Forefront of Innovation<br>We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.<br>As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.<br>What You’ll Do:<br>• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.<br>• Participates in investigator meetings as necessary. Identifies potential<br>• investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.<br>• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.<br>• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).<br>• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.<br>• Responds to company, client and applicable regulatory requirements/audits/inspections.<br>• Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.<br>• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.<br>• Contributes to other project work and initiatives for process improvement, as required.<br>Education and Experience Requirements:<br>• Bachelor's degree in a life science related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</p><br><ul><li><b><span>Total experience:</span></b><span>at least 3 years as a CRA</span></li><li><b><span>Oncology experience:</span></b><span>at least 2 years of on-site, hands-on experience</span></li><li><b><span>Location:</span></b><span>central Poland</span></li></ul><p><br>• Valid driver's license where applicable.<br>Knowledge, Skills and Abilities:<br>• Proven clinical monitoring skills<br>• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology<br>• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents<br>• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving<br>• Ability to manage Risk Based Monitoring concepts and processes<br>• Good oral and written communication skills, with the ability to communicate effectively with medical personnel<br>• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues<br>• Good organizational and time management skills<br>• Effective interpersonal skills<br>• Attention to detail<br>• Ability to remain flexibile and adaptable in a wide range of scenarios<br>• Ability to work in a team or independently as required<br>• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software<br>• Good English language and grammar skills<br>• Good presentation skills<br>Working Conditions and Environment:<br>• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.<br>• Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.<br>• Exposure to biological fluids with potential exposure to infectious organisms.<br>• Personal protective equipment required such as protective eyewear, garments and gloves.<br>• Exposure to fluctuating and/or extreme temperatures on rare occasions</p><br> </div><h2 data-automation-id="subHeaderPreferredCandidate" class="h5"> Preferred candidate </h2> <div class="row is-m v-align-top t-small bg-mute"> <div class="col is-3 p5" data-automation-id="label_Years_of_experience"> <b>Years of experience</b> </div> <div class="col is-9 p5" data-automation-id="data_Years_of_experience"> No experience required </div> </div> <div class="row is-m v-align-top t-small "> <div class="col is-3 p5" data-automation-id="label_Degree"> <b>Degree</b> </div> <div class="col is-9 p5" data-automation-id="data_Degree"> Bachelor's degree / higher diploma </div> </div>

<h2 class="h5">Job description</h2> <div class="t-break" data-jb-field="description"> <p><b>Work Schedule</b></p><br>Standard (Mon-Fri)<p><b>Environmental Conditions</b></p><br>Office<p><b><u>Job Description</u></b></p><br><p>Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation<br>The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.<br>What You'll Do:<br>• Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.<br>• Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.<br>• Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.<br>• Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.<br>• May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.<br>• May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.<br>• May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.<br>Education &amp; Experience Requirements:<br>• Bachelor's degree or equivalent and relevant formal academic / vocational qualification<br>• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).<br>In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.<br>Knowledge, Skills, Abilities:<br>• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams<br>• Good planning and organizational skills to enable effective prioritization of workload<br>• Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization<br>• Capable of working effectively in a changing environment with complex/ambiguous situations<br>• Familiarity with the practices, processes, and requirements of clinical monitoring<br>• Good judgment and decision making skills<br>• Effective oral and written communication skills, including English language proficiency<br>• Capable of evaluating workload against project budget and adjusting resources accordingly<br>• Sound financial acument and knowledge of budgeting, forecasting and fiscal management<br>• Strong attention to detail<br>• Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.<br>• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.<br>Working Conditions and Environment:<br>• Work is performed in an office environment with exposure to electrical office equipment.<br>• Frequently drives to site locations and frequently travels both domestic and international.<br>Why Join Us?<br>When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.<br>Apply today to help us deliver tomorrow’s breakthroughs.</p><br> </div><h2 data-automation-id="subHeaderPreferredCandidate" class="h5"> Preferred candidate </h2> <div class="row is-m v-align-top t-small bg-mute"> <div class="col is-3 p5" data-automation-id="label_Years_of_experience"> <b>Years of experience</b> </div> <div class="col is-9 p5" data-automation-id="data_Years_of_experience"> No experience required </div> </div> <div class="row is-m v-align-top t-small "> <div class="col is-3 p5" data-automation-id="label_Degree"> <b>Degree</b> </div> <div class="col is-9 p5" data-automation-id="data_Degree"> Bachelor's degree / higher diploma </div> </div>