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Job available in 4 locations: Berlin, Munich, Hamburg, Remote Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description About Us At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Through our PPD® clinical research services, we support clinical trials in more than 100 countries, delivering laboratory, digital and decentralized solutions that help bring life-changing therapies to patients faster. Our global Clinical Operations teams provide end-to-end clinical trial support — from study start-up through close-out — across commercial and government-sponsored studies. Why Join Thermo Fisher Scientific / PPD? • Work on high-quality, global clinical trials across diverse therapeutic areas • Be part of a stable, well-established organization with long-term career opportunities • Strong collaboration with experienced CTMs and project teams • Clear development pathways (e.g. Lead CRA, CTM) • Flexible working models that support work-life balance • Permanent employment • Full-time (40 hours/week) or Part-time (32 hours/week) options available About the Role We are seeking a highly experienced Principal Clinical Research Associate (CRA) to lead and coordinate all aspects of clinical monitoring and site management for complex clinical trials. Acting as a subject-matter expert and site process specialist, you will ensure trials are conducted in accordance with the approved protocol, ICH-GCP, applicable regulatory requirements, and internal SOPs—ensuring subject safety, data integrity, and continuous audit readiness. In this principal-level role, you will manage complex and high-risk studies across multiple sponsor and monitoring models (e.g. FSO, FSP, government-sponsored research). You will serve as a key escalation point for sites and project teams, take a leadership role on assigned studies, and actively contribute to the mentoring and development of junior and senior CRAs alike. What You’ll Do Principal-Level Clinical Monitoring & Oversight • Lead monitoring activities for complex, high-risk, or strategically important clinical trials using a risk-based monitoring approach • Independently conduct on-site and remote monitoring visits in line with approved monitoring plans • Perform and oversee SDR, SDV, and CRF review, ensuring the highest standards of data accuracy and integrity • Evaluate investigational product accountability through physical inventory and records review • Ensure essential documents are complete, inspection-ready, and compliant with ICH-GCP and applicable German/EU regulations • Lead site initiation, maintenance, and close-out activities, providing expert guidance and recommendations Quality, Risk & Issue Management • Apply advanced root cause analysis (RCA), critical thinking, and problem-solving methodologies to identify systemic site issues • Strategic Project & Stakeholder Collaboration • Serve as a trusted partner to investigative sites, sponsors, and internal project teams • Identify trends across sites and studies and provide strategic recommendations to the Clinical Team Manager (CTM) • Ensure accurate and timely updates of study systems (e.g. CTMS) and perform QC reviews where required • Participate in investigator meetings and support investigator identification and feasibility activities • Support investigator payment processes and trial financial oversight as applicable Leadership, Mentorship & Process Improvement • Actively mentor, coach, and support the development of junior and senior CRAs • Contribute to project-specific and functional training initiatives • Identify opportunities for process optimization and drive implementation of improvements • Provide expert input into monitoring strategies and clinical operations best practices Administrative & Operational Responsibilities • Maintain timely and accurate completion of timesheets, expense reports, and required documentation • Maintain frequent communication with sites between visits to ensure ongoing compliance and issue resolution • • Drive corrective and preventive actions (CAPAs) to resolution and proactively mitigate risk • Author high-quality monitoring reports and follow-up correspondence in a timely manner • Act as a key escalation point for significant site issues, protocol deviations, and compliance risks • Support and lead activities related to audits, inspections, and regulatory inquiries Education & Experience • Bachelor’s degree in a life sciences related field or equivalent qualification • Minimum 5+ years of experience as a Clinical Research Associate / Monitor • Valid driver’s license • Full right to work in Germany • Fluency in German and English (C1 level) – interviews will be conducted in German Knowledge, Skills & Abilities • Strong clinical monitoring skills with hands-on RBM experience • Excellent understanding and application of ICH-GCP and applicable regulations • Solid therapeutic area knowledge and medical terminology • Well-developed critical thinking, problem-solving, and root cause analysis skills • Strong written and verbal communication skills with medical professionals • High attention to detail and strong organizational skills • Ability to work independently while contributing effectively to cross-functional teams • Flexibility and adaptability in a dynamic project environment • Proficiency in Microsoft Office and ability to learn clinical systems (e.g., CTMS) Locations: Home-based or hybrid anywhere in Germany FTE: Full-time (40 hrs/week) or Part-time 80% (32 hrs/week) Contract: Permanent Travel: Approximately 50–75% (study-dependent) Severely disabled applicants with the same aptitude will be given preferential treatment. 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