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Senior Clinical Trial Associate

TFS HealthScience · Copenhagen, Capital Region, DK

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout...

Job description

About this role TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. The Senior Clinical Trial Associate is responsible for coordinating and maintaining study documentation and supporting clinical trial operations to ensure compliance with ICH GCP, SOPs, and regulatory requirements. You will play a key role in supporting the study team across all phases of the trial, from start-up through close-out. As part of our SRS FSP team, you will be dedicated to one sponsor and support the execution of a Phase 2 clinical study within cardiology. Key Responsibilities: Set up, maintain, and close the Study Master File, ensuring completeness and compliance with GCP requirements Maintain and update study information in CTMS in collaboration with CRAs and Project Manager Support study start-up, maintenance, and close-out activities across sites and countries Assist with preparation and coordination of regulatory submissions, amendments, and essential d...