Clinical Operations Coordinator in Egham

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 e TMF management and inspection readiness , with the successful candidate acting as the primary e TMF 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.
• e TMF Management & Inspection Readiness
• Act as the primary administrator and business owner for the electronic Trial Master File (e TMF).
• 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.
• 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 (e TMF) .
• 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 e TMF and CTMS systems , alongside strong Microsoft Office skills.