临床项目管理（副）经理

1. Assist the Operation Project Lead in developing and managing comprehensive, integrated project plans, timelines, and budgets for assigned clinical trials from start-up through close-out.

2. Act as the primary daily operational contact for CRO partners and vendors, handling routine queries and coordination, and manage their performance against key milestones, budget, and quality deliverables.

3. Provide hands-on management of in-house trials, including site selection, initiation, and oversight, by coordinating with CRAs and serving as the *** point of contact for resolving site issues. Drive the study team to meet critical milestones while maintaining budget and quality standards.

4. Ensure all trial activities adhere to ICH-GCP, SOPs, and regulatory requirements. Support preparation for and follow-up of internal audits and regulatory inspections. Track and help implement corrective and preventive actions (CAPAs).

Qualifications

1. Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.

2. Minimum 5 years of clinical trial experience within a pharmaceutical, biotech or CRO; oncology experience preferred.

3. Solid knowledge of GCP/ICH guidelines.

4. Highly proactive and organized, with strong problem-solving abilities.

5. Excellent team player.