Clinical Trial Manager — Outsourced Studies Lead

Precigen; Germantown (MD); On-site; USD 110,000 - 160,000; Full time

Job summary

Precigen, a clinical-stage biopharmaceutical company, seeks a Clinical Trial Manager to oversee day-to-day operational management of outsourced studies, ensuring CROs deliver on time and within budget while keeping TMF inspection-ready. This role spans Clinical Development or Medical Affairs depending on study needs.

You will develop integrated study plans, manage start-up activities, monitor enrollment, review data, and support audits.

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.

Responsibilities

• Serve as day-to-day operational lead for cross-functional study teams and CROs.
• Develop and maintain integrated study plans, timelines and milestones.
• Lead start-up activities: country/site selection, regulatory submissions with CRO.
• Track enrollment/retention; manage recruitment contingency actions with CRO and sites.
• Contribute to protocol, ICF, CRF and monitoring plan development for operational design.
• Perform ongoing clinical data review; triage deviations and data trends.
• Support investigator meetings, site training and Q&A; prepare content for CSRs.
• Maintain TMF completeness; keep the study inspection-ready at all times.
• Coordinate audits/inspections and CAPAs; escalate significant findings to ops leadership.

Skills

Interpersonal communication

Written communication

Time management

Organizational skills

Attention to detail

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

CTMS (eTMF) systems

Veeva Vault

Budget tracking software

Job description

Precigen, a clinical-stage biopharmaceutical company, seeks a Clinical Trial Manager to oversee day-to-day operational management of outsourced studies, ensuring CROs deliver on time and within budget while keeping TMF inspection-ready. This role spans Clinical Development or Medical Affairs depending on study needs.

You will develop integrated study plans, manage start-up activities, monitor enrollment, review data, and support audits.