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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 developing strategies for patient enrollment, data quality, and risk management throughout the clinical trial lifecycle.
Highest-signal resume keywords
Clinical Trial ManagementOncology Clinical TrialsGood Clinical Practices (GCP)Drug Development ProcessTeam Leadership
ATS Keywords
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Hard Skills
Clinical OperationsProtocol DevelopmentData ManagementRisk Based Quality ManagementTrial Master File MaintenanceRegulatory Inspection PreparationPatient Enrollment StrategiesMonitoring Plan DevelopmentData Trend AnalysisIssue Escalation
Soft Skills
LeadershipCommunicationNegotiationOrganizational SkillsProblem-Solving
Industry Keywords
Clinical TrialsCRO ManagementPhase II/III TrialsInternational StudiesLife Sciences
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide strategic leadership and operational oversight of complex global clinical trials.
- Lead study deliverables at assigned sites, countries, or regions from protocol development support through study closeout and inspection readiness.
- Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
- Serve as the 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, including informed consent forms, investigator agreements, CRFs, analysis plans, monitoring plans, data management plans, and safety monitoring activities.
- Review and approve essential document packages and critical study deliverables.
- Lead Risk Based Quality Management activities and resolve signals and actions.
- Review CRO monitoring trip reports, evaluate monitoring quality, identify cross-site trends and risks, and resolve findings and action items.
- Perform quality oversight visits focused on inspection readiness.
- Lead and review clinical data listings, reports, and dashboards; identify data trends and risks and drive cross-functional resolution.
- Oversee Trial Master File maintenance, quality, and completeness and lead TMF quality reviews.
- Ensure clinical trial activities comply with Good Clinical Practices and national and international regulatory requirements.
- Lead audit and regulatory inspection preparation and support inspection management.
- Manage, mentor, and guide CTMs, CRAs, and other Clinical Operations team members.
- Drive continuous improvement initiatives and contribute to Clinical Operations processes and standards.
- Represent Clinical Operations on cross-functional study teams and governance meetings.
- Perform all other duties as assigned.
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% depending on project needs.
- Proven capabilities to interpret complex scientific concepts and critically assess clinical data.
- Proven proficiency in overseeing large complex studies managed in-house and by a CRO.
- Demonstrated ability to problem-solve regarding regulatory requirements, external parties, timelines, and complex clinical programs.
- Demonstrated 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, ICH guidelines/GCP, and all phases of clinical trial execution.
- Ability to apply clinical trial knowledge to complex, global studies.
Benefits
Comp & perks- Bonus
- Stock
- Benefits and/or other applicable variable compensation