Clinical Project Manager
3 weeks ago
About the Opportunity
As a Clinical Trial Manager, you will be responsible for managing local-level trial activities for trials in the Asia Pacific region. Reporting to the Clinical Research Manager, you will lead studies following ICH-GCP guidelines, corporate SOPs, and regulatory requirements.
Duties
- Lead drug development plan input projects and conduct trial feasibility and site selection
- Oversee trial start-up activities, including budget negotiation and forecasting
- Coordinate ethics and regulatory submissions
- Facilitate recruitment activities and liaise with vendors
- Ensure CRAs are trained and monitoring trials according to requirements
- Maintain Corporate Clinical Trial Management System and oversee TMF activities
- Participate in global teleconferences and local team meetings
- Prepare for and participate in trial audits and inspections
- Execute trial close-out activities successfully
Requirements
- Min 2 years of Clinical PM experience within a sponsor or CRO environment
- Tertiary qualifications in biological, health, or medical sciences, pharmacy, nursing, or medicine
- Postgraduate qualifications highly regarded
- Research and project management experience with functional knowledge of local regulations
- Experience leading a clinical project team
About the Company
Join a global pharmaceutical leader known for innovative drug development and a strong presence in the Asia Pacific region. This company specializes in various therapeutic areas and is renowned for its commitment to improving health outcomes worldwide, offering a collaborative and dynamic work environment.
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