Local Study Associate/ Sr CTM - Cell and Gene Therapy France/Poland - FSP

<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>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.</p><p></p><p><span>Our global Clinical Operations colleagues within our clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.</span></p><p></p><p><b>The FSP Solution:</b></p><p>PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.</p><p></p><p>Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.</p><p></p><p><b>Discover Impactful Work:</b></p><p>To lead local study teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with international guidelines such as ICH-GCP as well as relevant local regulations.  In addition may perform site monitoring as needed to support the flexible capacity model.  The position is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.</p><p></p><p><b>A Day in the Life:</b></p><p>• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.<br/>• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies<br/>• Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations.<br/>• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.<br/>• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.<br/>• Ensures timely submission of <span>application/documents</span> to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of <span>application/documents</span> for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.<br/>• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.<br/>• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.<br/>• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations.<br/>• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs.<br/>• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).<br/>• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.<br/>• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.<br/>• Reviews monitoring visit reports (as required and following SOP