Lead the development of the operational plans for clinical deliverables for assigned complex and/or multiple studies in parallel, effectively implementing design excellence in line with the Clinical Development Plan (CDP) and ensuring the principles of Good Clinical Practice (GCP).
Ensure operational plans and activities are in line within the assigned studies.
Collaborate with CQA to establish an auditing plan for assigned studies to ensure timely resolution of CQA audit findings at the global study or program level and collaborate with Inspection readiness to ensure study is ready for inspection (if applicable).
Ensure operational plans and activities are in line within the assigned studies.
Collaborate with CQA to establish an auditing plan for assigned studies to ensure timely resolution of CQA audit findings at the global study or program level and collaborate with Inspection readiness to ensure study is ready for inspection (if applicable).
Requirements:
BA degree (preferred Graduate/MSc degree) in applicable discipline and a minimum of 5 years of related experience
At least 4 years of experience pharmaceutical industry or clinical research site based experience
Knowledge of ICH GCP guidelines
Computer literate
Fluent in English
Experience Preferred:
Global trial experience preferred
Monitoring experience preferred
Must be able to travel with overnight stays, as necessary, travel up to 30%
BA degree (preferred Graduate/MSc degree) in applicable discipline and a minimum of 5 years of related experience
At least 4 years of experience pharmaceutical industry or clinical research site based experience
Knowledge of ICH GCP guidelines
Computer literate
Fluent in English
Experience Preferred:
Global trial experience preferred
Monitoring experience preferred
Must be able to travel with overnight stays, as necessary, travel up to 30%
This position is open to all candidates.
