• Promote the success of clinical trials focused on creating value for patients and research teams by actively contributing or leading communities and work product teamso Sponsor of the Community of Practice Regulatory and Submissiono Member of the Community Agreement and Fair Market Valueo Member of the Community Digitalization, Decentralization and Data Privacyo Work product Onboardingo Work product Site Activation• Actively contribute to all stages for deployment of clinical studies in various therapeutic areas by developing a strategy to ensure the success of clinical trial programso Thorough planningo Effective site recruitmento Transparent communicationo Proactive risk management• Participate in cross-functional projects, dedicated to optimizing processes, strengthening the efficiency of clinical research, identifying and addressing emerging needs• Promote patient orientation within all Clinical Operations• Inspire and enhance talent• Proactively develop partnership and collaborative approaches with all internal and external stakeholders by creating alignment, removing potential barriers and obstacles while applying new ways of working to achieve the company vision• Enable all teams to perform at their best, fostering a growth mindset and maximizing talent potential and development

• Responsible for the supervision of the Startup and CRA teams• Responsible for detailed annual performance reviews (mid and end-year), individual development plan or talent development• Responsible for appropriate management and resolution of performance issues• Define and measure in country performance indicators• Assign the workload and engage with resource management• Oversight of all country-level client deliverables and timelines• Communicate management strategies• Develop and maintain effective relationships with teams in a matrix environment• Provide input to the relevant SOPs• Involved in transversal training activities• Staff recruitment and on boarding• Country point of contact for client relations or business development (sponsor affiliates)• Subject matter expert for startup processes and regulatory monitoring• Hold Clinical operations staff accountable for compliance with the project plans, adherence to monitoring visit (site selection, site initiation, monitoring, close out), source data verification, trip report, issue resolution, eTMF and time deliverable obligations• Conduct on site accompanied field visit activities• Have GCP oversight ensuring trainings are executed, understood and implemented• Identify and escalate GCP issues through regular interactions with the direct reports• Coach CRA to own effective investigator and site staff relations and oversight

• Country regulatory expert responsible of CA submission• Coordinate and collect of clinical trial study packages and submissions to CA - Activities in coordination with regulatory department, medical team and partners (CRO, distribution site …)• Primary point of contact near French Competent Authority (ANSM) and head office for regulatory activities• Subject matter expert country regulations• Communication to local and international team members (CRA, TL Group, Regulatory group, project’s lead …) by providing trainings/presentations, regular update of regulatory data base, documents associated to SOP …• Point of contact for internal local SOP review• Writing of local specific documents for Competent Authorities and Ethics Committee• Maintain concise and current project status report• Track progress of deliverables in tracking tool • Provide regular input in collaborative relationship, internally and with CRO partner• Improvement of data architecture and creation of monitoring tables shared with Safety Department and Medical teams• Point of Contact for vendor operations team (CRO management)• Responsible to update of French data base for patients included in biomedical research

• Responsible for all aspects of study site monitoring including pre-study and site initiation visits, routine monitoring and close-out visits, maintenance of study files, liaison with vendors• Responsible for all aspects of site management• Ensure the site is audit readiness at any moment and the investigator oversight is ensured• Prepared and submit accurate and timely trip reports• Undertook feasibility or site selections• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation• Assist with training of new employees or CRA, e.g. co-monitoring• Coordinated local clinical projects • Act as point of contact for clinical trial supplies (IMP, laboratory kits and Ancillary supplies), other suppliers (vendors) and Sponsor• Review progress of projects and initiate appropriate actions to achieve target objectives • Participate in the development of study documents• 5 years of experience as outsourced CRA• Investigator meeting: study presentation – regional session with up to 50 Investigators• Design and review of study documents to be consistent with study protocol (CRF, ICF, study synopsis, prescription sheet, patient card, labels ...)• Responsible of the investigator/site payments• Ensure investigator site study files are inspection ready at any time• Experience from phase II to phase IV