Clinical Project Manager

Axcynsis Therapeutics is seeking a highly motivated Clinical Project Manager (CPM) with hands-on experience managing clinical trials in China and/or the United States, preferably in Oncology and Antibody Drug Conjugates (ADCs). Experience working across both China and U.S. clinical development programs is highly desirable.

You will be responsible for the end-to-end planning, management and execution of clinical trials, including start-up, regulatory and ethics submission coordination, CRO and vendor oversight, site selection and management, patient recruitment oversight, study conduct, data and safety oversight, clinical trial documentation, quality and inspection readiness, and study close-out.

The successful candidate will play a key role in leading clinical trial execution, CRO and site oversight, clinical operations processes, and inspection readiness, while supporting the development and implementation of Axcynsis' clinical operations infrastructure, including its eTMF system and SOPs.

Key Responsibilities:
Clinical Trial Project Management: Lead the planning, initiation, execution, and close-out of clinical trials in China and/or the United States. Develop and maintain overall study timelines, milestones, budgets, risk plans, and project plans. Coordinate cross-functional activities across Clinical Operations, Medical, Regulatory, Pharmacovigilance, Data Management, Biostatistics, CMC, and other relevant functions. Lead regular study team meetings and maintain study action items, risks, issues, and mitigation plans. Ensure clinical trial activities are conducted in accordance with the protocol, ICH-GCP, applicable FDA/NMPA requirements, and other applicable regulations. Oversee overall study progress and proactively identify and resolve issues that may affect study timelines, quality, budget, or execution.

CRO & Vendor Management: Serve as the primary point of contact for CROs and other clinical vendors supporting assigned studies. Coordinate CRO selection, onboarding, scope of work, timelines, deliverables, and ongoing performance. Monitor CRO performance against agreed timelines, budgets, quality standards, and study milestones. Review CRO work plans, project plans, study reports, and other key deliverables. Manage CRO budgets, invoices, and change orders, as applicable. Identify, escalate and support resolution of operational, quality, budget and timeline issues with CROs and vendors. Ensure effective communication between CROs, clinical sites, internal teams, and other external stakeholders.

Clinical Operations & Site Management: Oversee clinical trial start-up activities, including site identification