Ensure compliance with ich-gcp and local regulations
Manage site identification, qualification, and monitoring
The role requires leading the Local Study Team to deliver clinical studies according to agreed resources, budgets, and timelines while ensuring strict compliance with AZ Procedural Documents and international guidelines
Job Summary
The role requires leading the Local Study Team to deliver clinical studies according to agreed resources, budgets, and timelines while ensuring strict compliance with AZ Procedural Documents and international guidelines.
Responsibilities include overseeing the entire site lifecycle from identification and qualification through initiation, monitoring, and closure, as well as managing critical documentation like informed consent forms and study budgets.
The position demands excellent project and risk management skills to proactively identify complex study problems, facilitate resolutions, and ensure timely data delivery of required quality.
Matching Summary
The role requires leading the Local Study Team to deliver clinical studies according to agreed resources, budgets, and timelines while ensuring strict compliance with AZ Procedural Documents and international guidelines.
Skills & Requirements
Must-have
Lead Local Study Team at country level
Ensure compliance with ICH-GCP and local regulations
Manage site identification, qualification, and monitoring
Oversee study budget and financial agreements
Coordinate regulatory submissions to EC/IRB and authorities
Nice-to-have
Ability to use Artificial Intelligence in operations
Experience with therapeutic area knowledge
Strong negotiation skills for vendor management
Proactive risk management and crisis handling
Coaching skills for junior team members
Key Requirements
Bachelor degree in life science or related discipline
Minimum 5 years experience in Development Operations (CRA/SrCRA)
Excellent knowledge of ICH-GCP and local regulations