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 UnitedStates, 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:

1. Clinical Trial Project Management

· Lead the planning, initiation, execution, and close-out of clinical trials in China and/or theUnited 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, applicableFDA/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.

2. CRO & VendorManagement

· 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 betweenCROs, clinical sites, internal teams, and other external stakeholders.

3. Clinical Operations& Site Management

· Oversee clinical trial start-up activities, including site identification and selection, feasibility, contracting, regulatory/ethics submissions, site activation, and initiation.

· Oversee patient recruitment and retention activities and proactively identify and address recruitment or site-performance issues.

· Provide study-level oversight of clinical site performance and coordinate with CRAs/CROs on monitoring activities, site issues and corrective actions.

· Support site initiation, investigator meetings and study-specific site training, as required.

· Coordinate with CRAs andCROs on regular site monitoring, follow-up and close-out activities.

· Coordinate with Medical and Pharmacovigilance teams on safety-related operational activities and ensure timely escalation of safety issues.

· Oversee operational aspects of study data review, query resolution, database activities and coordination with Data Management and Biostatistics.

· Track and support resolution of protocol deviations, site issues and other study-related operational issues.

4. Quality, TMF &Inspection Readiness

· Ensure Clinical Operations team members complete required training and maintain appropriate training compliance.

· Coordinate SOP rollout and training within Clinical Operations.

· Oversee maintenance of the eTMF and ensure timely filing of essential documents.

· Prepare and maintain regular summaries of eTMF completeness and inspection readiness.

· Support clinical site inspection readiness for studies conducted under Axcynsis Therapeutics, whether directly managed or outsourced to CROs.

· Support preparation and conduct of QC activities in accordance with the applicable QC Plan.

· Identify and follow up on issues arising from audits, inspections, monitoring, or incident findings.

· Support the review, development and implementation of SOPs and clinical operations processes as required.

· Other duties as required

Qualifications:

· BSc, MSc or PhD in life sciences or a related field;

· Minimum 3-5 years of clinical project management or clinical operations experience, preferably within a pharmaceutical or biotechnology company.

· Proven track record in independently managing early-phase (especially Phase 1) clinical trials in China and/or the United States; experience across both jurisdictions is highly desirable.

· Prior experience in oncology trials is essential; ADC experience is a strong advantage.

· Strong vendor and site management capabilities.

· Solid understanding of U.S. FDA and China NMPA regulations and clinical trial/IND requirements, as well as ICH-GCP guidelines.

· Proficient with TMF systems, CTMS, and other relevant clinical trial platforms.

· Demonstrated experience in CRO and clinical vendor management, including oversight of CRO performance, timelines, deliverables, budgets, and issue escalation.

· Excellent leadership, interpersonal, and problem-solving skills. Ability to work both independently and collaboratively within a dynamic biotech startup environment.

· Fluency in both English and Chinese (written and spoken) is required, with the ability to communicate effectively with U.S. and China-based sites, vendors, CROs, and other stakeholders.