Clinical Project Manager

1 week ago

Singapore YISHENG BIOPHARMA (SINGAPORE) PTE. LTD. Full time

**Essential Functions**
- Plan, coordinate and implement all the tasks generated by clinical trials
- Participate in data review and interpretation to ensure overall project successEnsures that all assigned clinical trials are carried out according to the required timelines, budget, and quality standard
- Ensure good initiation of the clinical sites, and the Investigators are informed of the trial specifications.
- Collaborate with CRO Project Manager to ensure proper oversight and conduct of clinical trials
- Tracks and forecasts budget, metrics, timelines progress for all project deliverables to enable better project decisions
- Keep the Investigators and the Health Authorities informed of the trial’s updates and results
- Provide regular updates to Management team on the progress of the trials, any issues encountered and proposed solutions
- Write / validate the technical and/or administrative study documents which are necessary for the trial and make the Corporate documents fit the the test protocol, SOP,ICH GCP, China GCP and relevant regulations
- Participate in audit preparations and follow-up on subsequent Corrective Actions and Preventive actions (CAPA) until closure
- Provide relevant trainings to CPA and CRA whenever necessary

**Essential Requirements**
- Bachelor’s Degree in Health Science/Pharmacy and related field
- Experience in managing vaccine projects will be an advantage
- Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding vaccine/drug development phase, clinical research and data management methods
- Excellent interpersonal skills
- Adaptability to handle a range of different tasks simultaneously

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