Senior Clinical Trial Manager - Lead Cross-Study CROs

Precigen, Inc; Germantown (MD); On-site; USD 140,000 - 155,000; Full time

Job summary

Precigen, Inc. in Germantown, MD is seeking a Senior Clinical Trial Manager to lead day-to-day operations for outsourced studies, ensuring on-time, on-budget, inspection-ready delivery.

You will coordinate with cross-functional teams and CRO partners to drive study plans, timelines, and feasibility. The role requires 7+ years in clinical research, expertise in ICH E6(R3), TMF standards, and experience with CTMS/eTMF systems.

Qualifications

• 7+ years of clinical research experience, including 5+ years managing studies at a sponsor or CRO.
• Demonstrated oversight of outsourced studies and CRO partners.
• Working knowledge of ICH E6(R3), FDA and EU CTR requirements, and TMF standards.
• Experience in Immunology, Oncology, Hematology preferred; Phase 2-4 and post-approval study experience valued.
• Proficiency with CTMS and eTMF (e.g. Veeva Vault) and study budget tracking.

Responsibilities

• Lead day-to-day operational management for outsourced studies with CROs.
• Develop integrated study plans, timelines and budgets.
• Oversee site start-up, regulatory submissions and feasibility.
• Track enrollment and retention against plan; manage risks.
• Coordinate with Medical, Data Mgmt and Biostatistics on data review.
• Ensure TMF completeness and audit readiness.

Skills

Project management

Cross-functional collaboration

Attention to detail

Verbal and written communication

Ethical standards

Education

Bachelor's degree in life sciences, nursing, pharmacy or related field

Advanced degree preferred

Tools

CTMS

eTMF (Veeva Vault)

Job description

Precigen, Inc. in Germantown, MD is seeking a Senior Clinical Trial Manager to lead day-to-day operations for outsourced studies, ensuring on-time, on-budget, inspection-ready delivery.

You will coordinate with cross-functional teams and CRO partners to drive study plans, timelines, and feasibility. The role requires 7+ years in clinical research, expertise in ICH E6(R3), TMF standards, and experience with CTMS/eTMF systems.