bioprojet pharma
- CRA coordinator
2014 - maintenant
* Participation to FDA inspections preparation (sponsor & investigator sites).
Project management from start up to closure, planning, ensure projects conduct in compliance with budgets, timelines and standards of quality (SOPs, ICH/GCP)
* Primary contact for vendors (clinical monitoring, start-up team, regulatory, safety, DM, MW, medical monitoring, records management, contract & legal, finance and QA)
* Selection and management of vendors (CROs, central lab, IWRS, ePRO, translation companies, printers, couriers, ).
* Budgets management, forecasts, Work Orders & agreements (sponsor, vendors, Investigators), pass through costs, fees and invoices approvals.
* Preparation and attendance to Bid defence, kick-off and blind review meetings, organisation and presentation at investigator and monitor meetings, lead face to face meetings and international teleconferences with project teams, sponsors and vendors.
* Project metrics assessments, reporting to Project Manager.
* Creation of study documents: study plans, ICFs, guidelines, manuals, monitoring tools, protocol amendments, CRF/eCRFs set up including edit checks, DM and safety reporting plans review,
* Coordinatination and input in clinical study reports preparation.
* Management of study logistics: IPs, CRFs, IWRS, central labs,..
*Management of clinical operation aspects: coordination and management of CRAs
(Europe, America Latina, north Africa), training of project teams to protocols and procedures, mentoring of CRAs, set up monitoring priorities, visit reports review, monitoring planning and progress, coordination of Ethics Committees and regulatory submissions.
* Attendance to vendors and sites audits, coordination and answers to audit reports, implementation of preventive and corrective actions.
* TMF set-up and maintenance including regular quality control coordination
* Coordination of feasibilities/ investigator selections, initiations, monitoring and close out visits
Specialties: * Global, international and national clinical trials phase I, II, III, IV and retrospective
Therapeutic areas: Hepato-Gastroenterology and Neurology
