Clinical Trial Manager II

Summit Therapeutics, Inc.

. Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities .

Posted 11/6/2026full-timeRemote • United Kingdom, IrelandMid-LevelSenior💰 $67,000 - $79,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical trial management, including oversight of Phase II/III trials, regulatory compliance, and risk management. Proficient in drafting and managing study-related documents while ensuring adherence to Good Clinical Practices and inspection readiness.

Highest-signal resume keywords

Clinical Trial ManagementRegulatory ComplianceRisk ManagementGood Clinical Practices (GCP)Data Monitoring Strategies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementData MonitoringStatistical Analysis PlansInformed Consent FormsInvestigator AgreementsRisk Based Quality ManagementClinical Data ReviewTrial Master File (TMF) ManagementPhase II/III Trial OversightInternational Clinical Trials

Soft Skills

Planning SkillsTime ManagementProject CoordinationProblem SolvingCommunication Skills

Industry Keywords

CROPharmaBiotechICH GuidelinesClinical OperationsMonitoring PlansQuality OversightStudy MeetingsOperational RisksClinical Trial Process

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities
Partner with the CRO to ensure robust clinical trial execution, data monitoring strategies, and patient enrollment strategies
Draft, review, and manage study-related plans and processes, including informed consent forms, investigator agreements, CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management, and safety monitoring as delegated
Review and approve essential document packages
Track and ensure resolution of Risk Based Quality Management actions and signals
Conduct sponsor oversight of CRO monitoring activities by reviewing monitoring reports, monitoring site performance, identifying quality trends, and resolving findings and action items
Perform quality oversight visits
Review clinical data listings, reports, and dashboards for currency and completeness
Identify trends and follow up on outstanding data issues with the CRO and study team
Oversee maintenance and completeness of the TMF and perform periodic quality reviews
Oversee clinical trial activities in accordance with Good Clinical Practices and ensure regulatory compliance
Ensure inspection readiness
Mentor and guide CTMs, CRAs, and other Clinical Operations team members
Perform other assigned duties

Requirements

What you’ll need

Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
6+ years of clinical trial management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
5+ years of direct clinical trial management experience including oversight of Phase II/III clinical trials
Ability to travel internationally to visit clinical sites and study meetings, up to 20%
Ability to comprehend complex scientific concepts and review and assess clinical data
Planning, time management, and project coordination skills
Ability to identify and manage operational risks and develop effective mitigation strategies
Ability to work independently and collaboratively in a fast-paced environment
Ability to solve problems and use sound judgment in relation to regulatory requirements, external parties, timelines, and moderately to highly complex clinical programs
Strong planning, communication, and organizational skills
Understanding of the drug development process, ICH guidelines/GCP, and each step of the clinical trial process

Benefits

Comp & perks

Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package
International travel opportunities, up to 20% depending on project needs