For one of our clients, we are currently looking for a Country study specialist (CSS).
You will have a coordinating role as the link between the therapeutic area lead/ country study managers and the CRA's.
Previous experience as CRA is a must, as well as a good knowledge of Dutch, French and English.
The country study specialist is responsible for providing coordination and operational solutions to support country study managers. The position also provides clinical trial oversight to local study teams to enable effective maangement of both global and local trials.
- Coordinates/supports operational aspects for implementation of clincial trial activities from study start-up through database lock, ensuring quality and safety standards, regulations, timelines and budget commitments are met
- Performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection
- Provides input into and/or develops study related materials such as Monitoring plans, Recruitment plans and Study newsletters
- Supports/coordinates the negotiation of site budgets, budget plans and provides oversight for site payments per contract
- Maintains effective and ongoing communication with CSM, supports communication with local study teams and sites
- Works with global study team and country study manager to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non-productive sites and tracking of safety procedures
- Supports management of country-level TMF and reviews for quality
- Is responsible for the coordination and oversight of local affiliate study level audit/ inspection audit action plan activities
- Provides feedback to local vendor manager and CSM on CRAs, and local supplier/vendor performance
- Coordinates study or country communication plan
- Previous experience as CRA, monitoring experience is required.
- Previous PM experience is an asset
- University degree or equivalent, in a medical/science related field
- Fluency in Dutch, French and English
- Good communication skills
015 21 11 04