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Senior Clinical Trial Manager

13 hours, 29 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 4

Description

  • Lead operational oversight of global clinical trials from start-up through closeout.
  • Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
  • Serve as the primary operational lead and escalation point for CROs, driving study execution, enrollment, retention, and data-quality strategies.
  • Draft, review, and approve study plans and documents, including informed consent forms, investigator agreements, CRFs, analysis plans, monitoring plans, and data management plans.
  • Lead risk-based quality management, monitor study performance metrics, and implement mitigation plans for identified risks and trends.
  • Oversee CRO monitoring activities, review trip reports, assess monitoring quality, and resolve critical findings.
  • Review clinical data listings, reports, and dashboards to ensure complete and current protocol-required data.
  • Maintain Trial Master File quality and completeness and lead TMF quality reviews.
  • Prepare for audits and regulatory inspections and support inspection management activities.
  • Mentor Clinical Trial Managers, CRAs, and other Clinical Operations personnel while contributing to process improvements and cross-functional governance.

Requirements

  • Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or a related health field preferred.
  • 8–10+ years of clinical operations experience within sponsor pharmaceutical or biotechnology organizations.
  • 7+ years of direct clinical trial management experience overseeing international Phase II/III oncology trials.
  • Experience leading large, complex studies managed both internally and through CROs.
  • Expert knowledge of the drug development process, ICH guidelines, GCP, and global clinical trial execution.
  • Ability to interpret scientific concepts and critically assess clinical data to support trial decisions.
  • Experience resolving regulatory, external-partner, timeline, and complex-program issues.
  • Strong planning, leadership, communication, negotiation, organizational, and judgment skills.
  • Ability to lead teams in a fast-paced, cross-functional environment.
  • Ability to travel internationally for clinical site visits and study meetings up to 20%, based on project needs.

Benefits

  • Salary range of £71,600–£85,000 GBP.
  • Total compensation may include bonus, stock, benefits, and other variable compensation.
  • Equal opportunity employer with a commitment to a diverse and inclusive workplace.

Interested in this position?

Apply directly on the company website

Apply Now

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