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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including site monitoring, patient recruitment, and compliance with ICH GCP and local regulatory requirements. Proficient in utilizing clinical trial management systems (CTMS) and electronic trial master files (eTMF) to ensure quality data collection and effective communication with stakeholders.
Highest-signal resume keywords
Clinical Trial ManagementSite MonitoringStakeholder EngagementRisk-Based Quality ManagementICH GCP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Research ExperienceSite ManagementData ManagementStudy Drug HandlingClinical Trial ExecutionRisk-Based MonitoringRemote Monitoring MethodologiesProblem SolvingOrganizational SkillsPatient Recruitment
Soft Skills
Effective CollaborationConfident CommunicationProactive ApproachCultural AwarenessCommitment to Quality
Tools & Technologies
CTMSETMFRemote Monitoring ToolsClinical Trial Systems
Industry Keywords
Clinical TrialsRegulated EnvironmentsOncology Clinical TrialsGlobal Clinical StudiesAudit Readiness
About the role
Key responsibilities & impact- Lead preparation, initiation, routine monitoring, and closeout of assigned clinical trial sites
- Serve as primary contact for investigative sites and support patient recruitment goals
- Train, support, and advise investigators and site personnel on study requirements, protocol execution, and Risk Based Quality Management
- Conduct onsite and remote monitoring visits, source data review, source data verification, and case report form review
- Identify, manage, and escalate site and study issues for timely resolution
- Perform site quality risk assessments and adapt monitoring activities throughout the study lifecycle
- Ensure timely reporting of serious adverse events, query resolution, and quality data collection
- Maintain study information in CTMS and other clinical systems
- Support collection, review, upload, and maintenance of essential documents in eTMF and investigator site files
- Collaborate with local study teams, quality colleagues, and stakeholders on audits, inspections, and study delivery
- Manage study supplies, study drug accountability, and related documentation
- Provide insights on site performance, investigator engagement, and local research landscapes
Requirements
What you’ll need- Based in the UK, ideally in the South West of England, or willing to travel there regularly
- Strong capabilities in site management, clinical monitoring, and stakeholder engagement
- Experience working within clinical research and regulated environments
- Effective collaboration across cross-functional teams and confident communication with investigators and site personnel
- Patient-focused mindset and commitment to quality, compliance, and operational excellence
- Comfort working with CTMS, eTMF, remote monitoring tools, and other clinical trial systems
- Strong organizational skills and ability to manage multiple priorities and timelines
- Proactive approach to problem solving and continuous improvement
- Bachelor’s degree in a life science or related discipline, or equivalent experience aligned with local market requirements
- Significant clinical research experience with demonstrated expertise in site monitoring and clinical trial execution
- Excellent knowledge of ICH GCP and working knowledge of applicable local regulatory requirements
- Good understanding of clinical study management, study drug handling, data management, and clinical trial processes
- Experience using CTMS, eTMF, and other clinical research technologies and systems
- Strong written and verbal communication, organizational, and problem solving skills
- Proficiency in written and spoken English
- Ability to travel nationally and internationally as required
- Valid driving licence in accordance with local country requirements, where applicable
- Preferred: experience supporting global clinical studies within pharmaceutical or biotechnology environments
- Preferred: familiarity with risk-based monitoring and remote monitoring methodologies
- Preferred: CRA/Senior CRA experience within Oncology clinical trials
- Preferred: experience supporting regulatory inspections and audit readiness
- Preferred: strong cultural awareness and global-team collaboration experience
- Preferred: demonstrated ability to identify efficiencies and contribute to high-quality clinical trial delivery
Benefits
Comp & perks- Health, Vision & Dental Insurance
- Vacation/Holiday/Sick Time
- Flexible benefit portal
- Car or car allowance (only applicable roles)
- Flexibility and growth opportunities