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Clinical Operations Coordinator
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Clinical Operations Coordinator
Location: Egham, Surrey
Working Pattern: Permanent, Full-Time | Hybrid – 3 days office / 2 days remote
Hours: Monday–Friday, 9:00am–5:30pm
About the Role
We are seeking an experienced Clinical Operations Coordinator to join a growing Clinical Affairs team within a specialist pharmaceutical organisation.
This is a hands-on role supporting both interventional and non-interventional clinical studies across the full study lifecycle, from start-up through to close-out. You will play a key role in coordinating study activities, supporting sites and vendors, maintaining clinical documentation, and ensuring studies remain compliant with ICH-GCP, applicable regulations, SOPs, and study-specific requirements.
A key focus of the position will be eTMF management and inspection readiness, with the successful candidate acting as the primary eTMF administrator and subject matter expert.
Key Responsibilities
Clinical Trial Operations
- Support the planning, implementation, conduct, and close-out of interventional and non-interventional clinical studies.
- Coordinate study activities, milestones, action items, and project tracking.
- Support the preparation and review of study documentation and clinical deliverables.
- Coordinate site initiation visits, investigator meetings, training sessions, and study team meetings.
- Facilitate communication between internal study teams, investigators, sites, vendors, and external stakeholders.
- Identify potential risks, delays, and issues and proactively escalate where required.
- Support the preparation and review of Clinical Study Reports and other study deliverables.
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eTMF Management & Inspection Readiness
- Act as the primary administrator and business owner for the electronic Trial Master File (eTMF).
- Establish and maintain study-specific TMF structures and filing plans.
- Ensure essential documents are collected, reviewed, quality checked, and filed appropriately.
- Conduct TMF health checks, completeness reviews, and reconciliation activities.
- Monitor TMF quality metrics and follow up on missing or overdue documentation.
- Lead TMF review activities to maintain ongoing inspection readiness.
- Develop and maintain TMF processes, guidance documents, and training materials.
- Support audits, regulatory inspections, and due diligence activities.
- Act as the internal subject matter expert for TMF compliance and document management.
Site, Regulatory & Vendor Support
- Support Clinical Specialists/CRAs and Study Start-Up Specialists across site selection, initiation, maintenance, and close-out.
- Assist with tracking site performance, recruitment metrics, and site issues.
- Review monitoring documentation for completeness and compliance.
- Support site payment activities and resolution of site action items.
- Assist with regulatory submissions and maintenance of essential clinical documentation.
- Maintain relevant clinical trial and PASS registers.
- Support vendor selection, qualification, contracting, and ongoing oversight.
- Coordinate vendor meetings and track actions and deliverables.
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Quality & Continuous Improvement
- Support compliance with ICH-GCP, clinical trial regulations, and company SOPs.
- Participate in audits, CAPAs, and quality improvement initiatives.
- Support safety reporting activities, including tracking, reconciliation, and maintenance of safety documentation.
- Identify opportunities to improve clinical operational processes, systems, and efficiency.
- Support the implementation of new technologies and processes.
- Provide training and support to junior team members where appropriate.
Requirements
- Bachelor's degree in Life Sciences, Biological Sciences, Nursing, Pharmacy, or a related discipline.
- 2–5 years' experience within Clinical Operations, Clinical Affairs, or Clinical Research in a pharmaceutical, biotechnology, medical device, or CRO environment.
- Experience supporting multiple clinical studies across different stages of the study lifecycle.
- Hands-on experience managing or coordinating an electronic Trial Master File (eTMF).
- Experience working with clinical study sites, investigators, and external vendors.
- Strong working knowledge of ICH-GCP and clinical trial regulations.
- Good understanding of TMF principles and inspection readiness.
- Experience supporting clinical study start-up, conduct, and close-out activities.
- Experience with eTMF and CTMS systems, alongside strong Microsoft Office skills.
Contact: eireann.evans@meetlifesciences.com
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