Senior CTM Program Manager - Clinical Trials (Shanghai)

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

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.