Job Opportunities

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.