Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality
Job Summary
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with sponsor’s Procedural Documents, ICH-GCP and local regulations.
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in clinical studies financial system.
Matching Summary
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
Skills & Requirements
Must-have
overall responsibility for study commitments
timely delivery of data to required quality
lead Local Study Team
compliance with sponsor's Procedural Documents
ICH-GCP and local regulations
clinical and operational feasibility assessment
Nice-to-have
team building and interpersonal skills
ability to prioritize and handle multiple tasks
motivate cross-functional teams
Key Requirements
Bachelor degree in related discipline
Experience in Clinical project management
prior monitoring background
Good knowledge of international guidelines ICH-GCP