Position: Clinical Trial Management (CTM) Program Manager
Hours: Full Time
Report to: Head of China
Location: Shanghai, China
About the Company
Dark Horse Consulting Group, Inc. (DHCG) is a rapidly growing life science consulting company that employs approximately 100 professionals across the United States, Europe, and APAC. We provide a comprehensive range of technical and strategic consulting services spanning the full spectrum of drug development and related business strategy to clients in the advanced therapies and biotherapeutics industries. Our clients include therapeutic developers, tools and technology companies, service providers, venture capital and private equity firms, and academic institutions. As the leading global consulting company in the advanced therapies space, we pride ourselves on providing high quality, expert service to enable the development of cutting-edge therapies for patients in need.
Position Summary
We are seeking a seasoned Clinical Trial Management Program Manager with full hands-on operational experience located in our China Office for our rapidly growing global consulting organization. This role reports to Head of China and has full responsibility to lead and oversee multiple clinical trials across our client portfolio. In this critical role, you will own the end-to-end delivery of clinical trials, from site startup to study closeout, ensuring quality, compliance, and on-time execution across CROs, sites, and internal stakeholders.
The ideal candidate will be a proactive, solutions-oriented leader with a proven track record in successfully managing complex clinical trial programs from start-up through close-out. You thrive in dynamic environments, excel at cross-functional collaboration, and possess exceptional organization and communication skills. China IIT project experience is a plus.
Responsibilities:
CRO & vendor management
- Lead the selection, contracting, and ongoing oversight of CROs and clinical trial vendors in collaboration with CRO management and key stakeholders.
- Hold CROs accountable to agreed deliverables, timelines, and quality standards throughout the study lifecycle.
End-to-end trial operations
- Oversee clinical operations across all study phases — working with CROs to execute each stage effectively, from study setup and site startup through enrollment, maintenance, interim/final analyses, study closeout, clinical study reports, and annual reports.
China IIT projects execution
- Collect and consolidate non-clinical and CMC reports into a comprehensive project report for review, submission and filing purposes.
- Plan and manage HSC/EC reviews, HGRAC approvals, and NHC filings.
Regulatory compliance & quality standards
- Ensure all clinical trials are conducted in full adherence to GCP, ICH guidelines, applicable local regulatory requirements, and internal SOPs and policies.
- Provide inputs into site audit report responses and maintain oversight of associated corrective action plans.
Performance monitoring & reporting
- Track KPIs and study metrics to assess trial quality and performance.
- Monitor study progress, budget, and timelines, and provide regular updates to internal stakeholders and reporting management.
- Escalate material issues promptly and with appropriate context.
Risk management
- Proactively identify quality and deliverable risks.
- Develop and implement mitigation plans in collaboration with relevant stakeholders to minimize impact on study timelines, data integrity, and patient safety.
Site relationships & oversight
- Cultivate strong working relationships with participating sites and serve as the sponsor's escalation point of contact for complex site issues.
- Conduct regular monitoring assessment visits to ensure sites are appropriately managed by assigned CRAs.
Cross-functional collaboration
- Partner closely with clinical function groups across the sponsor team and DHC to ensure alignment, accountability, and progress visibility.
- Drive coordination across functions to keep trial commitments on track.
- Bachelor's degree or above in life sciences, biology, pharmacy, clinical medicine or a related clinical discipline.
- 5+ years of clinical trial management experience in a sponsor or CRO environment, with hands-on ownership of trial delivery from startup to closeout.
- Strong command of GCP, ICH guidelines, and local regulatory requirements; experience within China (NMPA) frameworks is a strong advantage.
- Proven CRO oversight experience — including vendor selection, contracting, performance management, and issue escalation.
- Experienced in managing study budgets and timelines, with the ability to track metrics, identify variances early, and drive corrective action.
- Proactive risk management instincts — able to anticipate problems, structure mitigation plans, and communicate risks clearly to senior stakeholders.
- Comfortable working across clinical, regulatory, medical, and operational teams in a matrixed environment.
- Proficiency in CTMS, eTMF platforms, and standard tools such as Excel and PowerPoint. PMP or equivalent certification is a plus.
- Strong English communication skills (written and verbal); Mandarin proficiency is preferred given the China-based site network.
- Willingness to travel to clinical sites, CRO offices, and hospitals as required.
- In-depth knowledge in GCP and ICH guidelines
- Understanding of NMPA regulations and China IIT
- Native in Mandarin, Fluent in English
