Responsible for review of CRO/vendors financial and technical propositions and vendor selection. Management of clinical studies in collaboration with all involved partners (Academic and/or private partners, CRO etc.)Ensure achievement of deliverables within agreed timelines and budgetWork with all partners, CROs/vendors to create, review and manage study documentationInvolved in discussions about protocol design, strategy ans SOP creation Therapeutic area : Vaccines

Management of international clinical studies Phase I, II and III from start-up to trial completion in Europe, Asia, North America and Latin AmericaCoordination of CROs/vendors activitiesParticipate in the preparation and review of study all documents including protocols and Clinical Study Reports (CSR)Annual review of DSUR and Investigator’s BrochureActive participation in investigator meetings, bid defense meetings, kick off meetings etc.Review of CRO/vendors financial and technical propositions, participation to the vendor selection. Therapeutic area : Cardiology

Accountable for achieving delivery of clinical activities by meeting internal and external (client and regulatory) requirements according to time, quality, scope and budget constraints.Responsible for clinical monitoring plan and clinical study documents developmentIdentification of clinical risks and issues, development of mitigation plansResponsible for site monitoring activities (tracking and resolution of issues, review and approval of reports)Supervise IP accountability, subject enrollment, CRF monitoring, and query resolution; ensures all reporting systems are up to date, ensure proper filing of study documents in eTMF.Take active part in resources managementCollaborate with QA in case of internal or external audit, or for sites requiring implementation of CAPAEnsure that work is done in in adherence with scope and budget.Communicate with other Functional Leads, vendors and clientActively participate in client meetings, assisting with presentations as required. Provide performance / project status metrics internally and to the Sponsor.Active participation to investigator meetings, Bid Defense meetings, Kick off meetings and other client meetings.Experience in Phase II and Phase III studies in solids tumors and onco-hematology (AML, NHL, MF)

Coordination of the study activities within the study team (i.e; Clinops, Data management and Statistics)Develop clinical monitoring plan and clinical study documents including patient’s facing material (e.g. informed consent forms, patient's diaries, newsletters). Submission to the ECs and competent authorities Creation and update of the study tracking toolsMaintenance of the TMF, ensuring proper filing of study document and accuracyManagement of study budget and invoicingManagement of third vendors

Coordination of the external CROs activities (submissions, monitoring, logistical aspects, lab kits ....)Creation and update of the study tracking toolsResponsible for the global newslettersReview and validation of the study documents (eCRF, communication plan, monitoring plan, edit check plan...)

Responsible for site management activitiesOn-site visits (Selection visits, Site initiation visits, monitoring visits, close-out visits), management of queries and collection of essential documents.Involved in site contracts negotiation, signature and invoicingProvides project status metrics to the SponsorResponsible for site invoicing

Responsible for site management activitiesOn-site visits (Selection visits, Site initiation visits, monitoring visits, close-out visits), management of queries and collection of essential documents.Involved in site contracts and invoicing

Therapeutic areas : Renal Transplantation, Dermatology, Alzheimer and Depressive Disorder Phase II, III and IV Monitoring activities on site : selection, site Initiation, monitoring and close-out visits - Management of the sites : regular contacts to ensure compliance to study procedures, to keep motivation and enrollment - Payment activities (Invoicing)