Senior Clinical Trial Associate

Senior Clinical Trial Associate

Department: Clinical Operations

Reports to: Senior Director, Clinical Operations (day-to-day direction from the Clinical Project Manager)

Location: Remote working

Contract: Full-time contractor

Role purpose

A small, growing, clinical-stage gene therapy biotech is seeking a Senior Clinical Trial Associate (CTA) to provide day-to-day operational and administrative support to its clinical studies.

The successful candidate will help the Clinical Operations team keep studies inspection-ready, ensure vendors and sites are supported, and maintain accurate study trackers and documentation.

Key responsibilities

• Support the Clinical team with study start-up, conduct and close-out activities.
• Coordinate the shipment, receipt and tracking of study equipment and supplies to sites, including loan agreements.
• Support clinical activities with the APAC Team, local partners and CROs, including site documentation, training and tracking country-specific operational requirements.
• Prepare meeting minutes and risk, action, issue and decision (RAID) log updates for Clinical team meetings.
• Support the purchase order process with Finance, and vendor and consultant contracting, including CDAs, consultancy agreements, MSAs, work orders and change orders.
• Maintain the clinical trial insurance tracker, including policy renewals and enrolment figures, and support the relationship with the insurance broker.
• Maintain and quality-check the sponsor's eTMF, ensuring documents are filed correctly, completely and on time, and support periodic completeness reviews of CRO eTMFs.
• Support controlled-document management, including version tracking, filing of draft and final documents, and practical processes between SharePoint working files and the eTMF.
• Maintain study and sponsor oversight trackers, including the Clinical Operations action tracker, vendor issue log, and monitoring visit and TMF oversight, keeping evidence of CRO and vendor review, tracking issues and actions, and escalating persistent quality or timeline risks.
• Support compliance with GDPR, ICH-GCP and applicable regulations, including preparing data protection impact assessments (DPIAs) and records of processing activities (ROPAs).
• Contribute to simple, proportionate processes and templates for a growing Clinical Operations function.
• Provide flexible support across the portfolio during periods of high activity, recognising that priorities will evolve as studies progress.

Skills and experience

• Degree in a life sciences or related discipline, or equivalent experience.
• Experience in a clinical research setting (sponsor, CRO or site), ideally in a CTA, assistant or coordinator role.
• Working knowledge of ICH-GCP and the clinical trial lifecycle.
• Hands-on eTMF experience.
• Experience working with CROs and external vendors, and familiarity with contract processes.
• Excellent organisation, attention to detail and ability to manage multiple priorities.
• Strong written and spoken English; confident with Microsoft Office, SharePoint and tracking tools.
• Clear, professional communicator who works well across functions and with external partners.
• Comfortable working in a small, growing biotech environment where processes are still being developed and priorities may evolve.