Slough
• Management of all projects aspects, planning, Projects' conduct in compliance with the budgets, timelines and standards of quality (SOPs, ICH/GCP)
• Primary contact for sponsors and internal departments (clinical monitoring, start-up team, regulatory, safety, DM, MW, medical monitoring, statistics, records management, contract and legal, finance and QA).
• Selection and management of vendors (CRO, drug supplier, central lab, IxRS, ePRO, translation company, printer, courier)
• Management of study budgets, forecasts, agreements, OOS, pass through costs, invoicing approvals and budget reconciliations
• 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
• Creation of study documents: study plans, ICFs, guidelines, monitoring tools, protocol amendments, CRF/eCRFs set up including edit checks and DM plan review, review of the SAE reporting plan, participation in the preparation of clinical study reports
• Management of study logistics (IPs, CRFs, IxRS, central labs,...)
• Training of project teams to study protocols, procedures, mentoring of junior staff
• Management of clinical operation aspects: coordination and management of CRAs (Europe, USA and Latin America), monitoring planning, set up monitoring priorities, review of site visit reports, monitoring progress assessments, reporting to sponsors and to internal management
• Coordination of Ethics Committees and regulatory submissions
• Attendance to sponsor and internal audits, answer to audit reports, implementation of corrective actions
• TMF set-up and maintenance including regular QC coordination
• Coordination of feasibilities, sites' selections, initiations, monitoring and closures
Therapeutic Areas:
• Global, international and national clinical trials phase I, II, III, IV and retrospective,(Europe, USA and Latin Amercia:
Haematology, Oncology, Urology, Transplantations, Dermatology, Ophthalmology, Medical Device, Hepato-Gastroenterology, Neuropathy, Anemia, Pain, Nephrology and Pharmacogenetics
• experience in Hospital, within investigator group/association, pharmaceutical company and CRO
Mes compétences :
Chef de Projets
Coordination
Dermatology
Essais cliniques
Management
Médical
Medical device
Nephrology
Oncology
Ophthalmology
Pain
Urology
