Senior Global Oncology Trial Manager

Summit Therapeutics, Inc.

Princeton (NJ)

On-site

USD 158,000 - 185,000

Full time

28 hours ago
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Job summary

Summit Therapeutics Inc. is seeking a Senior Clinical Trial Manager (Sr. CTM) to provide strategic leadership and operational oversight of complex global oncology trials.

This role coordinates with sites, countries, and regions, managing study start-up through closeout and inspection readiness. The Sr. CTM will mentor CTMs and other Clinical Operations staff, oversee trial plans, data quality, and regulatory compliance, and partner with CROs to ensure timely, high-quality study execution across

Qualifications

  • Bachelor’s degree or equivalent in life science or health/medical-related area preferred.
  • 8-10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations.
  • 7+ years of direct clinical trial management experience overseeing phase II/III international oncology trials.

Responsibilities

  • Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
  • Leads CRO oversight of monitoring activities and enrollment strategies for high-quality study execution.
  • Drafts, reviews and approves study-related plans and documents including ICFs, CTAs, CRFs, and monitoring plans.
  • Reviews essential document packages and critical study deliverables.
  • Leads Risk Based Quality Management and drives mitigation of risks and actions.
  • Oversees TMF maintenance and TMF quality reviews.
  • Ensures compliance with ICH/GCP and regulatory requirements across trials.
  • Mentors CTMs, CRAs and other Clinical Operations team members.

Education

Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas preferred

Job description

Summit Therapeutics Inc. is seeking a Senior Clinical Trial Manager (Sr. CTM) to provide strategic leadership and operational oversight of complex global oncology trials.

This role coordinates with sites, countries, and regions, managing study start-up through closeout and inspection readiness. The Sr. CTM will mentor CTMs and other Clinical Operations staff, oversee trial plans, data quality, and regulatory compliance, and partner with CROs to ensure timely, high-quality study execution across

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