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Senior Clinical Trial Manager
Summit Therapeutics, Inc.. Provide strategic leadership and operational oversight of complex global clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing complex global clinical trials, ensuring compliance with Good Clinical Practices and regulatory requirements while leading cross-functional teams. Proficient in clinical data analysis, risk management, and developing strategies for patient enrollment and retention.
Highest-signal resume keywords
Clinical Trial ManagementGood Clinical Practices (GCP)Oncology Clinical TrialsClinical Data AnalysisRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Operations ManagementProtocol DevelopmentRisk Based Quality ManagementTrial Master File OversightStudy Planning and DocumentationPatient Enrollment StrategiesData Quality ManagementInternational Travel for Site VisitsPhase II/III Trial ExecutionCRO Oversight
Soft Skills
LeadershipCommunicationNegotiationOrganizational SkillsProblem-Solving
Industry Keywords
PharmaceuticalBiotechnologyClinical TrialsICH GuidelinesInspection ReadinessContinuous ImprovementCross-Functional TeamsStudy GovernanceClinical Data ListingsMonitoring Reports
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide strategic leadership and operational oversight of complex global clinical trials
- Lead deliverables at assigned sites, countries, or regions
- Support protocol development through study closeout and inspection readiness
- Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout
- Serve as primary operational lead and escalation point for CROs
- Develop and implement patient enrollment, retention, and data quality strategies
- Draft, review, and approve study plans, processes, and documents
- Review and approve essential document packages and critical study deliverables
- Lead Risk Based Quality Management activities and resolve signals and actions
- Oversee CRO monitoring activities, review monitoring reports, and address cross-site trends and risks
- Perform quality oversight visits focused on inspection readiness
- Review clinical data listings, reports, and dashboards; identify trends and risks
- Oversee Trial Master File quality and completeness and lead TMF quality reviews
- Ensure clinical trial activities comply with Good Clinical Practices and regulatory requirements
- Lead audit and regulatory inspection preparation and support inspection management
- Manage, mentor, and guide CTMs, CRAs, and other Clinical Operations personnel
- Drive continuous improvement initiatives and develop Clinical Operations processes and standards
- Represent Clinical Operations on cross-functional study teams and governance meetings
Requirements
What you’ll need- Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas 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 clinical trials
- Ability to travel internationally to visit clinical sites and study meetings, up to 20%
- Proficiency in reviewing, analyzing, and critically assessing clinical data
- Proficiency in overseeing large complex studies managed in-house and by a CRO
- Ability to problem-solve in relation to regulatory requirements, external parties, timelines, and complex clinical programs
- Ability to lead teams and work in a fast-paced team environment
- Excellent planning, leadership, communication, negotiation, and organizational skills
- Expert knowledge of the drug development process and ICH guidelines/GCP
- Deep understanding of all phases of clinical trial execution and ability to apply this knowledge to complex, global studies
Benefits
Comp & perks- Potential bonus
- Stock
- Benefits and/or other applicable variable compensation
- International travel opportunities, up to 20% as required by project needs