Clinical Trial Manager

Precigen, Inc•Germantown, MD

13h•$120,000 - $140,000

About The Position

The Clinical Trial Manager (CTM) is responsible for 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 CTM combines scientific understanding of the protocol with operational command of delivery, ensuring CRO and vendor partners execute on time, on budget, and in an inspection-ready manner. Studies may be in Clinical Development or Medical Affairs.

Requirements

Bachelor's degree in life sciences, nursing, pharmacy, or a related field.
At least 5 years of clinical research experience, including at least 3 years managing studies at a sponsor or CRO.
Demonstrated experience overseeing outsourced studies and CRO partners.
Working knowledge of ICH E6(R3), FDA and EU CTR requirements, and TMF standards.
Proficiency with CTMS and eTMF systems and study budget tracking.
Strong interpersonal, verbal, and written communication skills.
High degree of ethical standards and trustworthiness.
Strong time management and organizational skills, with the ability to manage multiple projects in a fast-paced environment.

Nice To Haves

Advanced degree.
Experience in Immunology, Oncology, or Hematology.
Phase 2–4 and post-approval study experience.

Responsibilities

Serve as the day-to-day operational lead for assigned cross-functional study teams and CRO study teams, escalating significant matters to Clinical Operations leadership.
Develop and maintain integrated study plans, timelines, and milestones; identify risks and implement or escalate mitigation actions.
Manage study start-up activities, including country and site selection input, feasibility, essential document strategy, and IRB/EC and regulatory submissions with the CRO.
Track enrollment and retention against plan and lead recruitment contingency actions with the CRO and sites.
Contribute to development of protocols, amendments, informed consent forms, case report forms, monitoring plans, and data management plans.
Perform ongoing clinical data review with Medical, Data Management, and Statistics teams; triage protocol deviations and data trends.
Support investigator meetings, site training, scientific Q&A, and preparation of study content for publications and clinical study reports.
Serve as the day-to-day sponsor operational contact for the CRO and specialty vendors.
Monitor vendor performance against contracts, KPIs, and quality expectations, escalating issues with documented evidence.
Review and approve vendor plans, risk-based samples of monitoring visit reports, and deliverables according to the oversight plan.
Track study budgets, accruals, and forecasts; review and reconcile CRO and vendor invoices against milestones and pass-through costs, escalating material variances.
Identify out-of-scope work early and partner with the Director on change orders.
Apply ICH E6(R3) risk-based quality management, including critical-to-quality factors, risk review, and quality tolerance limits.
Maintain TMF completeness and quality with the CRO and keep studies inspection-ready.
Support audits and inspections and manage study-related CAPAs, escalating significant findings to Clinical Operations leadership.
For Phase 3b/4, registry, real-world, and chart review studies, coordinate with Medical Affairs on study rationale, scientific review committee submissions, and publication timelines, applying oversight proportionate to study risk.
Perform other duties as assigned.