Senior Clinical Trial Manager

Summit Therapeutics Inc.

WorldwideFully remoteFull TimeSeniorHealthcare & Telemedicine
Posted 7h ago

Why we think you can apply

Hiring model
Open worldwide · the employer states no country restriction
Work from
Anywhere, the UAE included

Posted 7 hours ago · apply link checked 7 hours ago

About the role

Responsibilities

  • Oversee site selection, feasibility, activation, enrollment, monitoring and closeout for global trials
  • Serve as primary operational lead and escalation point for CROs
  • Lead risk-based quality management and sponsor oversight of CRO monitoring
  • Review clinical data listings, reports and dashboards for completeness and inspection readiness
  • Oversee Trial Master File quality and lead audit and inspection preparation
  • Manage and mentor Clinical Trial Managers, CRAs and Clinical Operations staff

Requirements

  • 8-10+ years clinical operations experience in pharma or biotech
  • 7+ years clinical trial management of phase II/III international oncology trials
  • Expert knowledge of ICH guidelines, GCP and drug development process
  • Strong planning, leadership, communication and negotiation skills
  • Ability to travel internationally (up to 20%)

Preferred Qualifications

  • Bachelor's degree in life science, nursing, pharmacy or related health field

About the Company

Summit Therapeutics is a biopharmaceutical oncology company with Phase 3 studies in NSCLC and colorectal cancer. Headquartered in Miami, Florida, with offices in California, New Jersey, the UK and Ireland.

What we look for

  • 8-10+ years clinical operations experience in pharma or biotech
  • 7+ years clinical trial management of phase II/III international oncology trials
  • Expert knowledge of ICH guidelines, GCP and drug development process
  • Strong planning, leadership, communication and negotiation skills
  • Ability to travel internationally (up to 20%)
  • Bachelor's degree in life science, nursing, pharmacy or related health field
Risk ManagementGCPOncologyCROClinical ResearchClinical OperationsICH
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