Our client is looking for a Global Clinical Trial Manager for a 12+ month contract. The ideal candidate has 10+ year of experience in both Sponsor and CRO environments. This CTM will be responsible for the management of a healthy volunteer, long term follow-up study of a vaccine product. 6,000 subjects, Phase III Study. They will also be accountable for executing multiple concurrent, complex clinical trials on-time and within budget in a highly dynamic and complex global environment. This role interacts significantly with internal and external functional groups to maintain and develop systems which promote regulatory compliance, enhance efficiency, and achieve organizational goals. This position plays a key role in supporting the Clinical Operations team in achieving its organizational goals. Global experience would be highly preferred from APAC or South America. In addition, it would be beneficial that the CTM’s therapeutic background is within Anti-Infective Drug / Vaccine studies.
- Collaborate with the Program Management team to create and maintain study timelines, risk registry and operational logistics and assess study progress to ensure all stakeholders are informed and aligned on trial deliverables.
- Responsible for the preparation and ongoing review of study documents throughout the lifecycle of the clinical trial.
- Lead Study Team Meetings including Study Kick-off Meetings, and may participate in Core Team meetings
- For government funded studies, collaborates with government agency, contracts group and external vendors to adhere to agency requirements.
- Manage and oversee the coordination of study start-up, conduct and close-out activities
- Manage and oversee monitoring and co-monitoring visits and trip report reviews according to the Clinical Monitoring Plan
- Responsible for data integrity and accuracy throughout the Clinical Trial lifecycle.
- Acts as clinical representative at regulatory inspections
- Education: Bachelor’s
- Clinical Trial Management
- Project Management
- Global / International Experience (APAC & South America Preferred)
- Phase III Study Experience
Remote: Senior Clinical Trial Manager (231535)