About TFS HealthScience:

TFS HealthScience is a global Contract Research Organization (CRO) committed to advancing health through tailored clinical research services. With over 800 professionals across 40+ countries, we specialize in key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—guide our work and successful partnerships. We are now expanding our efforts in the Medical Device sector, and we are looking for a dedicated Study Coordinator to join our team.

This role is sponsor-dedicated in Germany.

Position Overview:

We are looking for a Study Coordinator with some experience in medical device studies to support an important clinical project in Germany. In this role, you will manage study activities for a small group of participants over an 11-12 month follow-up period. The ideal candidate should know Good Clinical Practice (GCP), especially in following MDR and MPDG guidelines, and be able to communicate well in both German and English.

Key Responsibilities:

• Data Entry: Accurately enter data from Electronic Medical Records (EMR) and paper records into iMedidata case report forms.
• ISF Maintenance: Keep and organize Investigator Site Files (ISF) according to study protocols.
• Device Accountability: Complete and update device accountability logs, ensuring accurate documentation throughout the study.
• Study Coordination: Oversee and coordinate study-related activities at the site, making sure everything runs smoothly for the 3-4 enrolled participants.
• Compliance: Ensure all activities strictly follow ISO14155:2020 standards and German GCP requirements.

Qualifications:

• Certification: ISO14155:2020 certification and German GCP certification are necessary.
• Experience: Previous experience in coordinating medical device studies is required.
• Language Skills: You must be fluent in written and spoken German and English.
• Technical Knowledge: Basic knowledge of medical technology is needed to understand the source data and its context.

What We Offer:

• Part-Time Flexibility: Work 1-2 days per month over about 12 months.
• Professional Growth: Be part of an important medical device study, helping to advance health sciences.
• Supportive Environment: Join a global team that values trust, quality, and flexibility, and is committed to making a positive impact.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You will 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, including Poland, with flexible clinical development and strategic resourcing solutions across key therapeutic areas such as Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide us in attracting and retaining valuable talent who share our vision. These values drive high employee engagement and satisfaction. By aligning with these fundamental principles, 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.