Job Description

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

• Bachelor’s Degree in Health Science/Pharmacy and related field
• 6-10 years in the Biopharmaceutical/Pharmaceutical/Biotechnology/CRO industries, with at least more than 4 years of clinical project management. Candidate with more experience will be considered for Senior Manager role
• 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