Senior CRA I/II (m/f/d) - Germany

Thermo Fisher Scientific

Life Science

Karlsruhe, Baden-Württemberg - Deutschland

Senior Fachkraft / Projektleiter

Hybrid

Experteer Overview

In this Senior CRA role you ensure high-quality monitoring and site management across multicountry clinical trials. You will support end-to-end study conduct within the Clinical Operations team, ensuring regulatory compliance and data integrity. The position offers flexible location in Germany (home, office in Munich/Karlsruhe, or hybrid) and focuses on risk-based monitoring and collaboration with investigational sites. You will contribute to efficient trial delivery and quality assurance in a global portfolio.

Verantwortungsbereiche

Perform and coordinate clinical monitoring and site management activities
Conduct remote or on-site visits ensuring protocol, ICH-GCP, regulations and SOPs compliance
Maintain audit readiness and develop site relationships
Travel up to 50-75% to investigator sites
Ensure data accuracy via SDR, SDV and CRF reviews; manage site issues to resolution
Support investigator meetings and contribute to study status reporting
Update study systems (e.g., CTMS) and assist in preparation of project publications/tools
Assist in investigator site initiation, close-out, and essential document management
Facilitate communication among sites, client, and project team
Maintain administrative tasks (expense reports, timesheets)
Support process improvement initiatives via project work

Zentrale Anforderungen

Bachelor in Life Sciences or equivalent
2+ years of clinical research monitoring experience
Valid driver’s license
Right to work in Germany
German and English language proficiency at C1 level
Strong understanding of ICH-GCP and regulatory requirements
Good clinical monitoring skills and medical terminology knowledge
Proficient in Microsoft Office and CTMS familiarity
Ability to travel and work in a team or independently
Effective communication and problem-solving abilities

Critical thinking Strong written and verbal communication Attention to detail ICH-GCP expertise Risk-Based Monitoring (RBM)Site monitoring and SDV/SDR

Stellenbeschreibung

In this Senior CRA role you ensure high-quality monitoring and site management across multicountry clinical trials. You will support end-to-…

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