Ascentage Pharma · 16 hours ago
Clinical Trial Manager
United States
Full-time
Remote
Senior Level
6+ years expAscentage Pharma is a globally-focused, clinical-stage biopharmaceutical company specializing in developing novel therapies for various diseases. The Clinical Trial Manager will lead and oversee Phase I–II oncology clinical trials, ensuring compliance with timelines, budgets, and regulatory requirements while managing vendor partnerships.
BiopharmaBiotechnologyMedicalPharmaceutical
Hiring Manager
Jason A. Gilmore
Responsibilities
Lead the planning, execution, and day-to-day management of Phase I–II oncology clinical trials, partnering with CROs and vendors to ensure high-quality delivery on time and within budget
Serve as a primary operational point of contact for assigned studies, with increasing ownership across the full trial lifecycle—from protocol development through database lock and clinical study report
Manage CRO and vendor performance, including timelines, deliverables, and quality standards; contribute to RFP development and vendor selection
Oversee clinical trial documentation and ensure Trial Master File (TMF) completeness and continuous audit readiness
Partner cross-functionally with Clinical Development, Regulatory, Data Management, Quality, and external stakeholders to ensure compliant trial conduct in accordance with FDA/EU regulations and GCP/ICH guidelines
Track study timelines, enrollment progress, and milestones; proactively identify risks and implement mitigation strategies, escalating strategically when needed
Support investigational site identification and selection and maintain effective relationships with investigators, CRAs, and site personnel
Contribute to study budgets and provide clear, concise updates on trial progress to internal stakeholders and leadership
Qualification
Required
Bachelor's or Master's degree in life sciences, nursing, or a related field (or equivalent experience)
6+ years of clinical operations experience, including 5+ years managing clinical trials within a biotech or pharmaceutical environment
Hands-on experience with Phase I–II oncology trials strongly preferred
Strong project management and CRO/vendor oversight skills, with the ability to manage complex timelines and competing priorities
Solid understanding of global clinical trial regulations, GCP/ICH guidelines, and IND safety reporting
Experience maintaining TMFs and supporting audit and inspection readiness
Demonstrated ability to operate with a high degree of autonomy while remaining highly collaborative in a matrixed environment
Strong communication skills and executive presence appropriate for interaction with senior internal and external stakeholders
Preferred
Hands-on experience with Phase I–II oncology trials strongly preferred
Benefits
Medical, Dental, and Vision plans for employees and families
Employee paid life, STD & LTD as well as a comprehensive insurance package with spouse life Insurance, Critical Illness, and Accident Insurance
401K with a 6% company match
Liberal paid time off
Flexible schedules for staff and employee assistance program
Company
Ascentage Pharma
Ascentage is a clinical-stage biopharmaceutical company that develops drugs for the treatment of cancer.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$504.74MKey Investors
TakedaYuanMing CapitalSDIC Fund Management
2025-07-14Post Ipo Equity· $192.26M
2024-06-20Post Ipo Equity· $75M
2019-10-28IPO
Leadership Team
Yifan Zhai
Chief Medical Officer
Recent News
BioWorld Financial Watch
2026-01-09
2026-01-06
2025-12-05
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