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Clinical Trial Manager II

10 hours, 15 minutes ago
United Kingdom, Ireland
Full-time
Senior
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

  • Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
  • Partner with CROs on trial execution, data monitoring, and patient enrollment strategies.
  • Draft, review, and manage study plans and documents, including informed consent forms, investigator agreements, CRFs, monitoring plans, data-management plans, and safety-monitoring activities.
  • Review and approve essential document packages and oversee Trial Master File maintenance and periodic quality reviews.
  • Track and resolve risk-based quality management actions and signals.
  • Provide sponsor oversight of CRO monitoring activities, site performance, quality trends, monitoring findings, and action items.
  • Conduct quality oversight visits and ensure inspection readiness.
  • Review clinical data listings, reports, and dashboards for completeness and currency; resolve outstanding data issues with CROs and study teams.
  • Ensure clinical trial activities comply with GCP and national and international regulatory requirements.
  • Mentor CTMs, CRAs, and other Clinical Operations team members.

Requirements

  • Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or a related health/medical field preferred.
  • 6+ years of clinical trial management experience conducting international trials in a sponsor pharmaceutical or biotech organization.
  • 5+ years of direct clinical trial management experience, including Phase II/III trial oversight.
  • Global oncology clinical trial experience preferred.
  • Knowledge of the drug development process, ICH guidelines, GCP, and the full clinical trial lifecycle.
  • Ability to review and assess complex clinical data and scientific concepts.
  • Experience identifying operational risks and developing mitigation strategies.
  • Strong planning, time-management, project-coordination, communication, and organizational skills.
  • Ability to work independently and collaboratively in a fast-paced environment and exercise sound judgment regarding regulatory requirements, timelines, and external parties.
  • Ability to travel internationally for clinical-site visits and study meetings, up to 20% depending on project needs.

Benefits

  • Base pay range of $67,000–$79,000 USD.
  • Total compensation may include bonus, stock, benefits, and other variable compensation.
  • Compensation is determined based on skills, experience, certifications, and work location.

Interested in this position?

Apply directly on the company website

Apply Now

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