Overview
As a Clinical Trial Manager, you drive study setup, regulatory submissions, and site management to ensure compliant, timely trial execution. You work within the Clinical Solutions team to align with sponsor needs and deliver study milestones. You lead risk assessment, data integrity, and cross-functional coordination to protect patient safety and trial quality. This UK-based, home-office role offers hands-on ownership of study delivery within a globally regulated environment. You will collaborate with investigators, CRAs, and operations to shape efficient trial execution and trusted partner relationships.
Pay / Benefits
- career development and progression
- supportive line management
- technical and therapeutic area training
- peer recognition
- total rewards program
Responsibilities
- Lead study setup and regulatory submissions including initial and amendments
- Oversee site management and monitoring with emphasis on patient safety, protocol/GCP/compliance, and data integrity
- Manage site interactions from feasibility to closeout, including recruitment and investigator payments
- Identify data/process risks using RACT and implement mitigations
- Review scope of work, budget, and protocol content; communicate contractual parameters to the clinical team
- Use data and metrics to identify risks to deliverables and escalate if out of scope
- Participate in meetings (e.g., Kick Off) and act as escalation point to investigators and sites
- Coordinate delivery handoffs with cross-functional leaders to meet milestones (activation, enrollment, DB lock)
- Develop and maintain clinical study tools, CTMS, dashboards, and ensure user acceptance testing
- Provide initial and ongoing study team training on protocols, CRFs, SOPs, data plans, and timelines
- Monitor resource allocations for CRAs and study team, identifying delivery/quality risks
- Ensure quality and visibility of monitoring activities via approved systems and tracking tools
- Review project dashboards and systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS) for timely execution
- Ensure monitoring strategy, CMP/SMP, and risk plans are understood and followed
- Verify site monitoring documentation quality and ensure it reflects risk to compliance and data integrity
- Engage with client and other functions; provide status updates on deliverables and risks
- Propose solutions for obstacles and ensure compliance across functions (data management, start-up, recruitment, QA)
- Support inspections readiness and corrective actions as needed
- Oversee CRAs and Clin Ops Specialists and assess training/compliance; may support larger trials
- Provide performance feedback to line managers and contribute to staff development
Key requirements
- Bachelor’s degree or RN in a related field or equivalent
- Proven ability to lead and align teams to achieve milestones
- Experience working in an international environment
- Expertise in site management and monitoring
- Preferred experience with risk-based monitoring
- Understanding of clinical trial management financial principles and budget management
- Knowledge of GCP/ICH and regulatory requirements
- Good computer skills
- Strong communication, presentation and interpersonal skills
- Strong conflict resolution and problem-solving abilities
- Ability to apply risk management to trial conduct and ensure data quality
- Strong communication and interpersonal skills
- Conflict resolution
- Problem solving and critical thinking
- Risk-based monitoring
- Clinical Trial Management System (CTMS)
- Electronic Data Capture (EDC)
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