Germany Job Openings
TFS HealthScience
Clinical Research Associate
Hamburg
October 9, 2024
About the Role
As a Senior Clinical Research Associate with TFS Health Science, you will be a vital part of our SRS/FSP team, working exclusively with a world-renowned global pharmaceutical/biotech sponsor. You will play a crucial role in ensuring the quality and integrity of clinical trials, driving them forward from start to finish.
Key Responsibilities
- Submission & Amendment Support: Assist with initial and ongoing submissions, including amendments to ethics committees.
- Regulatory Reporting: Manage periodic reporting to ethics committees, including the reporting of safety events.
- Pre-activation & SIV Support: Contribute to site pre-activation activities and support Site Initiation Visits (SIVs).
- Monitoring & Site Management: Conduct both onsite monitoring and periodic central monitoring to ensure trial integrity; manage site relationships and processes.
- Documentation & Closeout: Maintain the e TMF (electronic Trial Master File) and lead closeout visits, ensuring compliance and completeness.
- Experience: Minimum of 5 years of clinical monitoring experience within a CRO, biotech, or pharmaceutical environment.
- Education: A Bachelor’s degree in a related field (Life Sciences, Nursing, etc.).
- Regulatory Knowledge: Strong understanding of ICH-GCP guidelines and regulatory requirements in the UK.
- Technical Skills: Proficiency in clinical trial management systems (CTMS) and e TMF platforms.
- Communication: Excellent written and verbal communication skills with the ability to interact effectively with site staff and sponsor representatives.
We provide a competitive compensation package, comprehensive benefits, and the opportunity for both personal and professional growth within a supportive and rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a real difference in the lives of patients.
Why TFS Health Science?
Founded over 27 years ago in Lund, Sweden, TFS Health Science has grown into a full-service, global CRO with over 800 professionals across more than 40 countries. We specialize in providing flexible clinical development and strategic resourcing solutions across key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—are the foundation of everything we do. These values guide our decisions at all levels and help us attract and retain top talent who share our commitment to excellence. Together, we foster a culture of innovation, mutual respect, and collaboration, driving us towards a healthier future for all.
Make a Difference with Us
Join TFS Health Science and be part of a team that’s making a real impact on global health. Apply now to take the next step in your career!
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