Lead Study Teams: Build and guide cross-functional, borderless study teams, establishing clear accountabilities, deliverables, and a psychologically safe environment where everyone can thrive.
Manage End-to-End Trial Operations: Maintain comprehensive study plans, risk mitigation strategies, site selection procedures, and vendor oversight protocols from activation through to clinical closure.
Oversee Financials & Agreements: Manage study budgets, track metrics, review work orders, and negotiate study agreements to ensure highly cost-effective operations with minimal variances.
Drive Global Regulatory Compliance: Ensure absolute adherence to international clinical trial guidelines (such as Good Pharmacovigilance Practices and Good Pharmacoepidemiology Practices), relevant local regulations, and inspection readiness.
Direct Vendor & Site Deliverables: Maintain strict oversight of external vendors, tracking performance metrics, resolving systematic operational issues, and organizing necessary training.
Develop Strategic Recruitment Plans: Analyze trial feasibility data across multiple countries to make data-driven recommendations on site distribution, patient numbers, and retention strategies.

Proven Clinical Leadership: Demonstrated experience leading successful study teams through all operational stages of clinical studies or secondary data use projects.
Regulatory Expertise: A clear understanding and practical experience applying global clinical quality requirements, regulations, and pharmacovigilance standards.
Strategic Planning & Risk Management: Strong organizational awareness with a proactive planning mindset, including the ability to embed operational contingencies.
Financial & Vendor Acumen: Experience successfully managing trial budgets, processing vendor agreements, and handling external system integrations.
Exceptional Communication: Well-developed written and verbal communication skills, with a proven ability to present clear directions, influence cross-functionally, and resolve conflicts.

Clinical Study Manager

Key skills