About the role
Job Summary
The Global Trial Leader (GTL) oversees the management of complex clinical trials globally, regionally, or locally. They lead the Clinical Trial Team (CTT) and serve as the primary clinical operations contact, ensuring end-to-end trial execution, including start-up, conduct, and close-out activities.
Key Responsibilities
- Provide operational oversight, including CRO selection, management, and performance assessment.
- Review protocols, vendor proposals, and study documents, contributing to study development.
- Coordinate study start-up activities such as site identification, feasibility, negotiations, and regulatory submissions.
- Define and track study timelines, milestones, and budgets, managing changes as needed.
- Address enrollment challenges, ensure compliance, and oversee vendor performance.
- Train study teams, facilitate kick-off meetings, and manage study documentation.
- Monitor study progress, quality, and regulatory adherence, including site visits and data review.
- Manage vendor relationships, study finances, and investigator/site engagement.
- Lead resource management, ensure timely resolution of data queries, and oversee trial closure and documentation archiving.
Qualifications & Skills
- Minimum 10 years of clinical study management experience, with 4+ years managing multinational trials.
- 3+ years in the therapeutic area of focus.
- Bachelor’s degree in life sciences, pharmacy, or nursing.
- Strong knowledge of ICH/GCP and regulatory requirements.
- Proficiency in MS Office, EDC, CDMS, and IRT systems.
- Excellent communication, leadership, and project management skills.
- Ability to work independently, prioritize tasks, and manage CRO/vendor relationships.