On-Site Clinical Operations Coordinator — eTMF & Compliance

Meet Life Sciences Ltd.; Leatherhead; Sur place; GBP 41 000 - 51 000; Plein temps

Résumé du poste

Meet Life Sciences Ltd. in Leatherhead, United Kingdom, is seeking a Clinical Operations Coordinator.

The role focuses on coordinating study activities, maintaining eTMF systems, and ensuring inspection readiness within regulatory standards and internal SOPs. You will support cross-functional teams, sites, and vendors to drive timely milestones, quality documentation, and regulatory submissions while mentoring staff and promoting process improvements.

Qualifications

• Bachelor's degree in Life Sciences, Biological Sciences, Nursing, Pharmacy, or similar.
• 2-5 years' experience in Clinical Operations, Clinical Affairs, or related roles in pharma, biotech, or CRO.
• Hands-on experience managing or coordinating an eTMF.
• Solid knowledge of ICH-GCP, clinical trial regulations, and documentation standards.
• Strong organizational skills with the ability to manage multiple studies independently.
• Excellent communication skills and attention to detail.
• Proficiency in eTMF, CTMS, and Microsoft Office.

Responsabilités

• Support planning, implementation, and close-out of clinical studies, ensuring milestones are achieved on time.
• Serve as the primary administrator for the electronic Trial Master File (eTMF), establishing and maintaining study-specific filing systems.
• Oversee clinical documentation quality, completeness, and audit readiness.
• Facilitate communication across study teams, sites, and vendors to drive seamless in site selection, initiation, and monitoring activities, ensuring compliance and performance.
• Support regulatory submissions, safety reporting, and inspection process improvements by identifying operational efficiencies and supporting the implementation of new systems.
• Contribute to training, mentorship, and onboarding of team members.

Connaissances

eTMF coordination

Clinical Operations

ICH-GCP

CTMS

Documentation

Formation

Bachelor's degree in Life Sciences

Outils

Microsoft Office

CTMS

Description du poste

Meet Life Sciences Ltd. in Leatherhead, United Kingdom, is seeking a Clinical Operations Coordinator.

The role focuses on coordinating study activities, maintaining eTMF systems, and ensuring inspection readiness within regulatory standards and internal SOPs. You will support cross-functional teams, sites, and vendors to drive timely milestones, quality documentation, and regulatory submissions while mentoring staff and promoting process improvements.