Senior Clinical Trial Manager - Trials Ops & Vendors

Precigen, Inc; Germantown (MD); On-site; USD 120,000 - 140,000; Full time

Job summary

Precigen, Inc. is seeking a Clinical Trial Manager (CTM) to lead day-to-day operational management of outsourced studies in Germantown, MD.

You will ensure studies run on time, within budget, and are inspection-ready, coordinating with cross-functional teams including Medical, Biostatistics, Regulatory, and CRO partners. The role requires 5+ years in clinical research, familiarity with ICH E6(R3) and TMF standards, and experience with CTMS/eTMF tools.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy or related field; advanced degree preferred.
• 5+ years of clinical research experience including 3+ 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

• Serve as the day-to-day operational lead for assigned cross-functional study teams and the CRO study team.
• Develop and maintain the integrated study plan, timelines and milestones; identify risks and mitigate.
• Manage start-up activities: country/site input, feasibility, essential document strategy, IRB/EC and regulatory submissions.
• Track enrollment and retention; lead recruitment contingency actions with CRO and sites.
• Contribute to protocol, amendment, ICF, CRF, monitoring plan and data management plan development.
• Perform ongoing clinical data review with Medical/Data Mgmt/Stats; triage deviations and trends.

Skills

Clinical trial management

Cross-functional coordination

Vendor management

Education

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

Advanced degree preferred

Tools

CTMS

eTMF (Veeva Vault)

Job description

Precigen, Inc. is seeking a Clinical Trial Manager (CTM) to lead day-to-day operational management of outsourced studies in Germantown, MD.

You will ensure studies run on time, within budget, and are inspection-ready, coordinating with cross-functional teams including Medical, Biostatistics, Regulatory, and CRO partners. The role requires 5+ years in clinical research, familiarity with ICH E6(R3) and TMF standards, and experience with CTMS/eTMF tools.