Senior Clinical Trial Manager
Summit Therapeutics Inc.
WorldwideFully remoteFull TimeSeniorHealthcare & Telemedicine
USD 158,000–185,000 a yearPosted 2 hours ago2h agoApply link checked 2 hours ago
Why we think you can apply
- Hiring model
- Open worldwide · the employer states no country restriction
- Work from
- Anywhere, the UAE included
Posted 2 hours ago · apply link checked 2 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 and approve study plans, consent forms, CRFs, and data management plans
- Lead TMF quality reviews and audit and inspection preparation
- Mentor CTMs, CRAs, and Clinical Operations team members
Requirements
- 8-10+ years clinical operations experience in pharma or biotech
- 7+ years managing phase II/III international oncology trials
- Expert knowledge of drug development, ICH guidelines and GCP
- Strong leadership, negotiation and communication skills
- Ability to travel internationally up to 20%
Preferred Qualifications
- Bachelor's degree in life science, nursing, pharmacy or related field
Benefits
- Total compensation may include bonus, stock, benefits and variable pay
About the Company
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality and duration of life. 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 managing phase II/III international oncology trials
- Expert knowledge of drug development, ICH guidelines and GCP
- Strong leadership, negotiation and communication skills
- Ability to travel internationally up to 20%
- Bachelor's degree in life science, nursing, pharmacy or related field
Regulatory ComplianceGCPOncologyClinical ResearchClinical OperationsCRO ManagementTMFPhase 3ICHRisk Based Quality Management
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Summit Therapeutics Inc.
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