Clinical Research Associate

vor 2 Wochen

Hamburg, Hamburg, Deutschland TFS HealthScience Vollzeit

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.

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