PM (Senior Manager or Manager)
Department: Clinical Operations
Job Title: PM (M-Sr. Manager)
Report to: Clinical Operations Director
Location: China
MAIN REPONSIBILITIES:
- Plan and organize the implementation of clinical studies to ensure that the studies are delivered on time, on budget and to quality as expected from planning, initiation, implementation, to completion.
- Organize clinical study teams and identify appropriate external vendors.
- Plan and manage clinical study budgets.
- Develops and tracks quality and risk management plans for clinical studies, organizes feasibility studies at the study, country and/or study center level, identifies participating countries and/or study centers, and develops subject recruitment strategies.
- Responsible for the preparation of clinical operation related documents, including clinical study required documents, ethics committee review materials, genetic resources related filings, and domestic and international clinical trial disclosures.
- Promote the establishment and operation of scientific committees or advisory boards related to research support.
- Develop the supply and management plan of clinical research drugs and equipment.
- Organize investigator/monitor meetings and ensure that they receive adequate and appropriate training
- Develop clinical monitoring plans and oversee their implementation and ensure the quality of clinical monitoring through co-monitoring or other means.
- Cooperate with audit planning and execution, and assist in the inspection activities of regulatory authorities when necessary.
- Organize regular internal and external meetings to maintain good communication and cooperation with internal study teams and external vendors.
- Regularly review clinical trial required documents to ensure their completeness and archive within the required timelines.
- Regularly report on study progress, milestones, and major risks and issues.
QUALIFICATIONS:
- Bachelor degree or above in life science related field, preferably in clinical medicine or pharmacology.
- 5 years or more clinical research related experience, preferably in clinical research projects or quality management.
- Experience in clinical research, familiar with ICH GCP and NMPA GCP, working experience in foreign pharmaceutical companies is preferred
- Strong communication and coordination skills.
- Excellent oral and written English.
