Mariette Codou Email & Phone Number

Paris, FR

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.

Paris, FR

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.

Raleigh, North Carolina, US

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.

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.

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)

Master I, Assistant De Recherche Et Developpement Du Médicament

Deust, Parfums, Arômes, Cosmétiques