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.

We are currently seeking a Clinical Trial Associate (CTA) to support the successful execution of clinical studies within a biotechnology environment. In this role, you will play a key part in maintaining clinical trial documentation, ensuring eTMF quality and compliance, and supporting the day-to-day coordination of study activities.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a biotechnology company at the forefront of innovation within oncology research.

Key Responsibilities

• Prepare, organize, maintain, and archive essential clinical trial documentation

• Manage and maintain the eTMF, ensuring completeness, quality, and inspection readiness

• Support document management activities, including DocuSign administration and R&D archiving

• Coordinate study meetings, site visits, and communication between sites, vendors, investigators, and internal study teams

• Prepare meeting materials, presentations, agendas, and meeting minutes

• Support study tracking activities and maintain information in CTMS and EDC systems

• Assist with ethics submissions, regulatory documentation, and study amendments

• Support operational study activities, including planning and budget tracking

• Ensure documentation complies with GCP, company SOPs, and applicable regulatory requirements

• Support audit and inspection readiness activities

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field

• Previous experience as a Clinical Trial Associate, Clinical Trial Coordinator, Study Coordinator, or similar clinical operations role

• Hands-on experience with eTMF management and clinical trial documentation

• Experience working with CTMS, EDC systems, and Microsoft Office applications

• Strong knowledge of GCP and ICH-GCP guidelines

• Excellent organizational and communication skills

• Fluent in English and Swedish, both written and spoken

Assignment Details

• Initial 12-month assignment

• Approximately 0.5 FTE

• Planned start in October

• Lund, Sweden

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.