Clinical Research Associate

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 looking for an experienced Clinical Research Associate (CRA) to support cell and gene therapy clinical trials at sites in Germany.

Please, keep in mind that this role is a direct-hire at one of our clients, a Big Pharma company.

Key Responsibilities

Manage site start-up, initiation, monitoring (remote and onsite), and close-out activities

Ensure protocol, GCP, and regulatory compliance at site level

Perform SDV / SDR, CRF review, and data quality oversight according to the monitoring plan

Support investigators and site staff through training and ongoing guidance

Drive site performance, proactively identifying and resolving issues

Ensure timely reporting of SAEs and follow-up documentation

Maintain inspection readiness, including ISF and essential documents

Ensure accurate and timely updates to CTMS and eTMF

Collaborate with data management, patient safety, and other stakeholders

Support audits and regulatory inspections as required

Qualifications

Bachelor’s degree in life sciences or a related field

Proven CRA experience in Cell & Gene Therapy (essential)

Strong knowledge of ICH-GCP and applicable local regulations

Solid understanding of clinical trial processes, monitoring, and data management

Experience with risk-based monitoring and remote monitoring approaches

Willingness to travel as required

Fluency in English and German

Must be based in Hamburg or Munich

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.