Description
For one of our Pharma clients we are seeking freelance support as:Senior Clinical Operations Manager France (M/F/D)
Tasks:
· Study Start – up support
· Support planning and execution of clinical trials Studies (NIS, preclinical, interventional)
· Monitoring Oversight
· Oversight Quality Management
· Site Quality Visits
· Preparation of SOPs in the clinical field
· Coordinating start up activities across assigned countries in partnership with the CRO
· Identifying and communicating risks to the global study team
· Oversee the CRO monitoring study sites to ensure effective identification
· Ensure that the CRO CRAs understand complex protocol processes and procedures
· May support CRA protocol-specific training
Qualification:
· Relevant experience with several years of direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies
· Good knowledge in study start-up
· Lead CRA/management experience preferred
· Nice to have: Experience Orphan drugs
· English & France (must have)
Requirements:
· Start: ideally: asap, latest: 01.08.2020
· Duration: until end of 2020 (Option for extension)
· Capacity: min. 4 days / week, ideally 5 days / week