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Senior Clinical Trial Manager

11 hours, 12 minutes ago
Anywhere
Full-time
Lead
Project Manager
Project and Program Management
Apply Now
Summit Therapeutics

Summit Therapeutics

Summit Therapeutics is a clinical stage drug discovery and development company dedicated to advancing innovative therapies to address serious unmet medical needs. With a focus on oncology, Summit is committed to improving the quality of life and increa...

Pharmaceuticals
51-200
Founded 2003
View All Jobs 2

Description

  • Lead global clinical trial execution from startup through closeout across assigned sites, countries, regions, studies, or programs.
  • Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
  • Serve as the primary operational lead and escalation point for CROs, driving enrollment, retention, data quality, and monitoring strategies.
  • Draft, review, and approve study plans and documents, including ICFs, CTAs, CRFs, analysis plans, monitoring plans, data management plans, and safety-monitoring activities.
  • Lead risk-based quality management, monitor study performance metrics, and implement mitigations for identified risks and trends.
  • Provide sponsor oversight of CRO monitoring through review of trip reports, monitoring quality, site trends, critical findings, and action items.
  • Review clinical data listings, reports, and dashboards; resolve cross-functional data issues and maintain inspection readiness.
  • Oversee Trial Master File quality, completeness, and quality-review activities.
  • Ensure trials comply with GCP and national and international regulatory requirements; prepare for audits and regulatory inspections.
  • Mentor Clinical Trial Managers, CRAs, and other Clinical Operations personnel, and represent Clinical Operations in cross-functional teams and governance meetings.

Requirements

  • Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or another health-related field preferred.
  • 8–10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations.
  • 7+ years of direct clinical trial management experience overseeing international Phase II/III oncology trials.
  • Expert knowledge of the drug development process, ICH guidelines, GCP, and all phases of global clinical trial execution.
  • Experience overseeing large, complex studies managed both in-house and through CROs.
  • Ability to interpret complex scientific concepts and critically assess clinical data to support trial execution and decision-making.
  • Demonstrated ability to manage regulatory requirements, external partners, timelines, and complex clinical programs.
  • Strong planning, leadership, communication, negotiation, organizational, problem-solving, and judgment skills.
  • Ability to lead teams in a fast-paced environment.
  • Ability to travel internationally for clinical site visits and study meetings, up to 20% depending on project needs.

Benefits

  • Base salary of $158,000–$185,000 USD.
  • Total compensation may include bonus, stock, benefits, and other variable compensation.
  • Compensation is tailored based on skills, experience, certifications, and work location.

Interested in this position?

Apply directly on the company website

Apply Now

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