- Prague, Prague, Czech Republic
- Mid
- 1+ years
Leading Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
Responsibilities
- Ensure overall responsibility for study commitments within the country and timely data delivery
- Lead Local Study Team consisting of CRA(s), CSA(s)
- Ensure compliance with Sponsor Procedural Documents, ICH-GCP and local regulations
- Perform clinical and operational feasibility assessment of potential studies
- Coordinate site selection process including initial Site Quality Risk Assessment and Site Qualification Visits
Requirements
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification