As a Project Manager, you will oversee the full lifecycle of international clinical trials, ensuring each phase aligns with regulatory requirements, approved budgets, and project timelines. You will act as the primary liaison between sponsors and internal teams, providing clear communication and strategic direction to keep studies on track.
Key Responsibilities
- Lead clinical study execution in compliance with ICH GCP, FDA regulations, and internal SOPs
- Coordinate cross-functional activities including data management, investigational supply logistics, biostatistics, and pharmacovigilance
- Develop and review essential study documents such as protocols, informed consent forms, study manuals, and site materials
- Deliver regular status updates to sponsors and internal stakeholders through reports and presentations
- Supervise clinical team members and mentor Associate Project Managers
- Monitor subject recruitment, retention, and protocol adherence across trial sites
- Support Trial Master File maintenance and lead TMF reviews when necessary
- Prepare for and participate in audits and regulatory inspections
- Collaborate with finance to ensure accurate and timely billing
- Contribute to client and investigator meetings, including onboarding and planning sessions
- Identify risks early and implement solutions to maintain project timelines
- Ensure all deliverables meet quality standards and regulatory expectations
Qualifications
- Bachelor’s degree in life sciences or a related field, or equivalent professional experience
- Minimum of 3 years in the pharmaceutical, biotech, or CRO sector
- At least 1 year of experience managing teams or leading projects
- Proficiency in MS Office applications, including Word and Excel
Work Environment
This role operates in a globally distributed setting, encouraging collaboration across time zones. The culture emphasizes integrity, inclusivity, accountability, and mutual support. Team members are empowered to share ideas, take initiative, and grow professionally in an environment built on shared values.
