Clinical Operations Coordinator

Overview

In this role you will coordinate clinical study activities from start-up to close-out as part of the Clinical Affairs team. You will ensure regulatory alignment and SOP compliance, supporting inspection readiness and timely milestones. The position focuses on cross-functional coordination with sites and vendors to drive efficient trial operations. You will contribute to training and onboarding to strengthen team capabilities. This opportunity lets you shape trial execution within a global organization committed to innovative therapies and patient outcomes.

Responsibilities

• Plan, implement, and close-out clinical studies with on-time milestones
• Administer the eTMF and maintain study-specific filing systems
• Oversee clinical documentation quality and audit readiness
• Coordinate communication across study teams, sites, and vendors
• Assist in site selection, initiation, and monitoring activities
• Support regulatory submissions, safety reporting, and inspection prep
• Drive process improvements and support new systems implementation
• Contribute to training, mentorship, and onboarding of team members

Key requirements

• 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 ability to manage multiple studies independently
• Excellent communication skills and attention to detail
• Proficiency in eTMF, CTMS, and Microsoft Office

• excellent communication
• strong organizational skills
• attention to detail
• eTMF
• CTMS
• Microsoft Office

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