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 Clinical Trial Associate (CTA) manages and maintains essential study documents, including the Study Master File (SMF), and coordinates documentation and contract-related tasks throughout clinical studies, ensuring strict adherence to company policies, SOPs, and regulatory standards.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in (fill in detail)

Key Responsibilities

• Assist in preparation and distribution of trial-related documents, tools, and templates.
• Support regulatory submissions and amendments (IEC/IRB/CA) and manage related processes.
• Assist with contract management, Investigator Payments, and documentation tracking
• Coordinate study supplies and documentation as delegated by the CRA/Project Manager.
• Initiate, maintain, and close the Study Master File (SMF) in compliance with GCP.
• Set up and maintain study information in the Clinical Trial Management System (CTMS).
  

Qualifications

• Experience in clinical trial administration, preferably within a global setting.
• Knowledge of clinical trial documentation, regulatory requirements, and GCP .
• Strong organizational and communication skills.
• Experience working with contracts and study documentation.
• Ability to coordinate multiple tasks and collaborate with cross-functional teams.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.