Manager/Associate Director, Clinical Operations

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.