Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.
This position offers a 1-year contract, with the possibility of renewal based on performance.
You will:
- Maintains study-specific and corporate startup tracking systems.
- Facilitates site budgets and contract negotiations.
- Supports site regulatory document collection.
- Under supervision, may prepare initial and amendment submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable).
- Communicates with the project team and investigational sites throughout the entire duration of the study.
- Develops site specific startup timelines and is responsible for meeting the site activation milestones.
- May review study specific translations.
- Supervises Trial Master File (TMF) maintenance throughout the study startup phase.