• Education : Medical, Pharmacy, Biology, and Immunology department, bachelor or above

• Excellent English, especially fluent Oral English

• At least 10years of experience in Clinical Project Management

• International clinical project management experience is preferred

• Oncology project management experience is preferred

• Strong communication skills and coordination skills

• Excellent problem solving

• Overseeing all ongoing clinical trial program

• Work with the clinical PM to help the development and implementation of clinical trials including planning, protocol design, selection of sites and investigators, conduct of studies, data management and assessment of results

• Is accountable for the conduct of GCP clinical trials in compliance with all relevant regulations and ethical standards

• Ensures compliance of clinical activities with all applicable health, safety, and environmental policies

• Ensures safety of clinical trials, thorough planning, monitoring and evaluation of ongoing study safety reviews, DSMB activities, dose escalation reviews, adverse event reports, etc.

• Manages the preparation of protocols, Investigator Brochures, clinical study reports, safety reports, and the clinical sections of, INDs/IMPDs, NDAs/MAAs, SOPs, investigation plans, abstracts and manuscripts

• Identifies, selects, negotiates and manages activities of CROs, external collaborators, clinical research centers and investigators

• Develops and maintains relationships with regulatory agencies and investigators

• Provides clinical expertise and input to research and development, business development and commercial efforts

• Part of the decision making leadership team.