Clinical Operation (AD/D)

  • Full Time
  • US

Website AnHeart Therapeutics

Department: Clinical Operations
Report to: Clinical Operations VP

 

MAIN RESPONSIBILITIES:
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.
Oversee CRO on the project performance and ensure successful delivery of study on time
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’s degree or above in a 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, familiarity with ICH GCP and NMPA GCP, and working experience in foreign pharmaceutical companies is preferred
Strong communication and coordination skills.

 

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