**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._ _Schwerbehinderte Bewerberinnen und Bewerber werden bei gleicher Eignung bevorzugt berücksichtigt._ Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.