Senior Clinical Trial Manager: CRO & Study Delivery Lead

Precigen; Germantown (MD); On-site; USD 110,000 - 165,000; Full time

Job summary

Precigen is seeking a Senior Clinical Trial Manager to lead day-to-day operations for outsourced studies, ensuring on-time, on-budget delivery and inspection readiness. You will partner with cross-functional teams across Clinical Operations, Medical, Biostatistics, Regulatory, and external CROs.

The ideal candidate has 7+ years in clinical research, hands-on CRO oversight, and working knowledge of ICH E6(R3), FDA/EU CTR requirements, and TMF standards.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy or related field.
• Advanced degree preferred.
• Experience with CTMS and eTMF systems is required or preferred.

Responsibilities

• Serve as day-to-day operational lead for cross-functional study teams and CRO study team.
• Develop and maintain integrated study plans, timelines, and milestones.
• Manage start-up activities: country/site selection, feasibility, regulatory submissions with CRO.
• Track enrollment and retention; lead recruitment contingency actions with CRO/sites.
• Support protocol, ICF, CRF, monitoring plan development to align with scientific questions.
• Perform ongoing clinical data review and triage deviations.
• Support investigator meetings, site training, and Q&A; prepare study content for publications.
• Act as sponsor operational contact for CRO and vendors; monitor performance against contract and KPIs.
• Review and approve vendor plans and deliverables; escalate variances.
• Track budgets, accruals, and invoices; escalate material variances to leadership.
• Identify out-of-scope work and coordinate change orders.
• Apply ICH E6(R3) quality management and maintain TMF completeness.
• Support audits/inspections and CAPAs for assigned studies.
• Coordinate with Medical Affairs for Phase 3b/4 and real-world studies.

Skills

Self-organization

Interpersonal communication

Attention to detail

Time management

Multi-project management

Education

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

Advanced degree preferred

Tools

CTMS

eTMF (Veeva Vault)

Job description

Precigen is seeking a Senior Clinical Trial Manager to lead day-to-day operations for outsourced studies, ensuring on-time, on-budget delivery and inspection readiness. You will partner with cross-functional teams across Clinical Operations, Medical, Biostatistics, Regulatory, and external CROs.

The ideal candidate has 7+ years in clinical research, hands-on CRO oversight, and working knowledge of ICH E6(R3), FDA/EU CTR requirements, and TMF standards.