Senior Clinical Trial Manager

Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company's AdenoVerse and UltraCAR-T therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.

POSITION SUMMARY:

The Senior Clinical Trial Manager (SCTM) is responsible for the day-to-day operational management and execution of one or more outsourced studies, from protocol concept through clinical study report, under the oversight of Clinical Operations leadership. The SCTM combines scientific understanding of the protocol with operational command of delivery, ensuring CRO and vendor partners execute on time, on budget and inspection-ready. Studies may sit in Clinical Development or Medical Affairs.

DUTIES AND RESPONSIBILITIES:

• Serve as the day-to-day operational lead for assigned cross-functional study teams (Clinical Sciences/Operations, Medical, Biometrics, Regulatory, CMC/supply, Safety, vendors) and the CRO study team for assigned studies and escalating significant matters to Clinical Operations leadership.
• Develop and maintain the integrated study plan, timelines and milestones; identify risks early and implement or escalate mitigation actions as appropriate.
• Manage start-up activities: country and site selection input, feasibility, essential document strategy, IRB/EC and regulatory submissions with CRO.
• Track enrollment and retention against plan; lead recruitment contingency actions with the CRO and sites.
• Contribute to protocol, amendment, ICF, CRF, monitoring plan and data management plan development so operational design supports the scientific question.
• Perform ongoing clinical data review with Medical, Data Mgmt/Stats; triage protocol deviations and data trends.
• Support investigator meetings, site training and scientific Q&A; prepare study content for publications and CSRs.
• Serve as day-to-day sponsor operational contact for the CRO and specialty vendors (e.g. central lab, IRT, eCOA, imaging, data management).
• Monitor vendor performance against contract, KPIs and quality expectations; escalate issues with documented evidence.
• Review and approve vendor plans, monitoring visit reports (risk-based sample) and deliverables per the oversight plan.
• Track assigned study budgets, accruals and forecast; review and reconcile CRO and vendor invoices against milestones and pass-throughs. Escalate material variances to Clinical Operations leadership.
• Identify out-of-scope work early and partner with the Director on change orders.
• Apply ICH E6(R3) risk-based quality management: critical-to-quality factors, risk review and quality tolerance limits.
• Maintain TMF completeness and quality in partnership with the CRO; keep the study inspection-ready at all times.
• Support audits and inspections; manage CAPAs arising from assigned studies. Escalate significant findings to Clinical Operations leadership.
• For Phase 3b/4, registry, real-world and chart review studies, the SCTM also coordinates with Medical Affairs on study rationale, scientific review committee submissions and publication timelines, and applies a proportionate oversight model suited to study risk.
• Other duties as assigned.

EDUCATION AND EXPERIENCE:

• Bachelor's degree in life sciences, nursing, pharmacy or related field; advanced degree preferred.
• 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.

DESIRED KEY COMPETENCIES:

• Self-organizer, highly motivated, and keen attention to detail.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Ability to understand and execute the company's mission and values.
• Maintain a high degree of ethical standard and trustworthiness.
• Exhibits an open mindset when approaching challenges and conflict.
• Ability to think and adapt to a rapidly changing environment and demands.
• Strong time management and organizational skills.
• Ability to manage multiple projects in a fast-paced environment.