Clinical Trial Management (CTM) Program Manager

Dark Horse Consulting Group; United States; On-site; USD 134,000 - 224,000; Full time

Job summary

Dark Horse Consulting Group is seeking a senior Clinical Trial Management Program Manager to lead end-to-end trial delivery from site startup to closeout for the China office. The role requires strong CRO oversight, regulatory compliance with GCP/ICH and local requirements, and proactive risk management.

You will coordinate cross-functional teams across sponsor, CRO, and internal stakeholders, ensuring on-time execution and high study quality in a dynamic global environment.

Qualifications

• Bachelor's degree in life sciences or related field.
• At least 5 years of clinical trial management with startup to closeout ownership.
• Strong command of GCP/ICH guidelines; China NMPA experience is a plus.
• CRO oversight including vendor selection, contracting and performance management.
• Experience budgeting and tracking timelines with proactive actions.
• Ability to work across regulatory, medical and operations in a matrixed setup.
• Proficiency in CTMS/eTMF; fluent English; Mandarin preferred.

Responsibilities

• Lead and oversee multiple clinical trials across client portfolio from site startup to closeout.
• Oversee end-to-end trial operations, enrollment, analyses, and study reports.
• Manage CRO/vendor relationships including contracting and issue escalation.
• Coordinate HSCEC/HGRAC approvals and NHC filings for regulatory compliance.
• Monitor KPIs, budgets, timelines; provide regular updates to stakeholders.
• Identify risks and develop mitigation plans to protect timelines and data integrity.
• Foster strong site relationships and monitor site performance and visits.
• Drive cross-functional collaboration across sponsor team and internal groups.

Skills

GCP/ICH knowledge

CRO oversight

Budget & timelines management

Risk management

Site management

CTMS/eTMF proficiency

English communication

Mandarin preference

Travel willingness

PMP certification (plus)

Education

Bachelor's degree in life sciences/related field

Tools

CTMS/eTMF systems

Excel

PowerPoint

Job description

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 interimfinal 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 HSCEC 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 sponsors 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

Qualifications

• Bachelors 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

Key Competencies

• In depth knowledge in GCP and ICH guidelines
• CRO oversight
• Understanding of NMPA regulations and China IIT
• Site management
• KPI tracking
• Risk mitigation
• CTMseTMF Clinical study reports
• Native in Mandarin
• Fluent in English