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 Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies 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 by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
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
lead local study team
compliance with ICH-GCP
clinical and operational feasibility assessment
site selection process
timely submission to EC/IRB
country financial Study Management Agreement
Nice-to-have
team building and interpersonal skills
ability to prioritize and handle multiple tasks
organizational skills
Key Requirements
Bachelor degree in Life Science
Experience in Clinical project management
prior monitoring background
Good knowledge of ICH-GCP
relevant local regulations
Proven ability to lead and motivate cross-functional teams