Job Description

Responsibilities: * Plan, coordinate and implement all the tasks generated by clinical trials * Participate in data review and interpretation to ensure overall project successEnsures that all as Responsibilities: 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 Requirements: 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