About the Role
Novotech is seeking an experienced Project Manager to lead the successful delivery of global clinical trials from study start-up through study close-out. As the primary point of contact for sponsors, you will manage project planning, execution, and financial performance while ensuring compliance with ICH-GCP and regulatory standards.
Responsibilities
- Lead end-to-end delivery of clinical studies from feasibility to close-out.
- Determine project feasibility and provide operational input for Business Development.
- Review project scope, timelines, and deliverables to ensure execution quality.
- Develop and monitor project plans, risk registers, and study tracking tools.
- Coordinate global cross-functional teams including Clinical Operations, Regulatory, Medical, and Data Management.
- Oversee project start-up, team training, and resource allocation.
- Manage project budgets, revenue forecasts, and profitability.
- Identify scope changes and manage change orders.
- Select and oversee external vendors including central labs and distribution providers.
- Identify and evaluate investigational sites and monitor recruitment performance.
- Partner with teams to ensure timely regulatory submissions and approvals.
- Review monitoring visit reports and support CRAs with issue resolution.
- Ensure TMF/eTMF maintenance and inspection readiness.
- Serve as the primary point of contact for sponsors and lead client meetings.
- Support the development of SOPs and operational process improvements.
Requirements
- Bachelor's degree in Life Sciences or a related discipline.
- Minimum 5 years of experience in the clinical research industry.
- Previous experience in Clinical Project Management or equivalent.
- Comprehensive knowledge of ICH-GCP and global clinical trial regulations.
- Proven experience managing global cross-functional clinical teams.
- Experience managing project budgets, timelines, and financial performance.
- Previous CRO experience.
- Experience across multiple therapeutic areas and global studies.
- Experience participating in Bid Defence Meetings.
- Vendor oversight and outsourcing management experience.
Skills
- Project leadership and delivery
- Risk management and problem-solving
- Stakeholder management
- Client-facing communication
- CTMS proficiency
- eTMF proficiency
- Financial forecasting
- Strategic decision-making
Location
- Remote
- UK
Work Type
- Remote
Experience Level
- Minimum 5 years
Education Level
- Bachelor's degree
Benefits
- Flexible working options
- Paid parental leave for both parents
- Flexible leave entitlements
- Wellness programs
- Ongoing development programs
- Mentorship opportunities
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- Founded in 1997 with 30+ offices across Asia-Pacific, the United States, and Europe.
- Recognized as an Employer of Choice and Great Place to Work.
- Committed to advancing therapies that improve patient outcomes worldwide.
Equal Opportunity
- Novotech is committed to being an employer of choice for gender equality and providing an inclusive work environment.
- We encourage applications from people who identify as LGBTIQ+, have a disability, or have caring responsibilities.
