Manager/Associate Director, Clinical Operations

Beijing or Shanghai, China

Key Responsibilities

  • Conduct end-to-end clinical trial management (start-up through close-out), ensuring adherence to GCP, SOPs, and regulatory standards.
  • Lead early feasibility efforts and country/site selection
  • Develop clinical trial/program budgets and liaise with Finance/Accounting in communicating budget forecasting and accruals
  • Develop timelines for assigned clinical trials and programs
  • Develop Request for Proposals (RFPs) and define scope of services for outsourced clinical activities
  • Identify and escalate project risks; assist in developing mitigation strategies.
  • Monitor performance of CROs, vendors, and investigative sites to ensure trial quality and data integrity.
  • Partner with Clinical Development, Medical Affairs, Data Management, and other functions to optimize study design and execution plans.
  • Contribute to the clinical content of Investigator’s Brochure (IB), Development Safety Update Report (DSUR), etc.
  • Partner with CROs to inspire superior performance and develop long-term partnerships to the mutual benefit of company and our service partners
  • Interact and establish relationships with clinical trial investigators and key opinion leaders

Qualifications

  • BS/BA required, advanced degree (MSc, PhD, PharmD, or MD) in life sciences, medicine, or related field preferred.
  • 10+ years of clinical operations experience (biotech/pharma/CRO), including at least 4+ years clinical study management experience. Prior exposure to global trial experience, e.g.. manage project in other countries rather than China.
  • Hands-on experience managing clinical trial processes and overseeing CROs/vendors.
  • Prior exposure to regulatory submissions (e.g., IND, NDA) or inspections is a plus.
  • Strong project management skills with ability to drive complex tasks independently.
  • In-depth knowledge of ICH-GCP, FDA/EMA regulations, and clinical trial operations.
  • Fluent in both spoken and written English communication.
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