Clinical Research Associate

TFS HealthScience

Hamburg or Munich, Germany

About the Role

As a Senior Clinical Research Associate with TFS HealthScience, 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 eTMF (electronic Trial Master File) and lead closeout visits, ensuring compliance and completeness.

Qualifications

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 eTMF platforms;
Communication: Excellent written and verbal communication skills with the ability to interact effectively with site staff and sponsor representatives.

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