Job Opportunities

Project Manager – Clinical Affairs Management

Responsibilities:

  1. Prepare, manage, execute and follow up on clinical-trial projects according to the related standards and timelines;
  2. Assist withcontract preparation, negotiation, signing and revision;
  3. Lead the project team members (internal and external) to complete the start-up, implementation and completion of clinical trials on schedule, and conduct overall quality control and management of the clinical trials project in strict compliance with clinical trial protocols and related regulations;
  4. Standardize the implementation and management of clinical trials to meet the requirement for new drug registration and approval;
  5. Manage the clinical trial routines, including but not limited to, the selection of both internal and external partners, the management and coordination of suppliers/CROs(outsourcers), and the training and management of CROs and external partners;
  6. Coordinate the clinical trial drug supply and clinical trial material supply effectively to meet the research requirement;
  7. Maintain timely communication with other departments to ensure the information related to the clinical trial project is effectively delivered and clinical trials are completed as planned;
  8. Other tasks as assigned by the manager.

Qualifications:

  1. More than 5 years experience in the pharmaceutical industry, at least 3 years experience in managing clinical trial projects;
  2. Bachelor’s degree or above, major in medical or biology;
  3. Familiar with medical terms, physiological terms, pharmacological terms and related rules and regulations;
  4. Excellent in both English and Chinese;
  5. Proficient at internal and external communications, detail oriented, positive attitude and able to undertake a variety of tasks in a fast-paced startup environment.

 

Medical Director

Responsibilities:

  1. Discuss the study protocol with the investigators;
  2. Review and approve patient enrollment;
  3. Review protocol compliance and manage protocol deviation;
  4. Study medical data review;
  5. Review and follow up serious adverse event;
  6. Manage queries from the clinical site staff;
  7. Provide medical opinion/review in the clinical study reports;
  8. Draft clinical studies summary and overview.

Qualifications:

  1. Bachelor degree in clinical medicine and MD/PhD preferred;
  2. At least 5+ year working experience in clinical medicine;
  3. At least 5+ years working experience in clinical development function of global biopharmaceutical industry preferred;
  4. Strong leadership, excellent communication and project management skills;
  5. Excellent in both English and Chinese.

 

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