About this role
Job available in 5 locations: Remote, Hamburg, Berlin, Frankfurt, Munich 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., Senior CRA, 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 This position is for experienced Clinical Research Associates with 2+ years of independent monitoring experience. You will manage clinical trial sites across Germany, ensuring studies are conducted in compliance with the protocol, ICH-GCP, applicable regulations, and company SOPs. You’ll work autonomously, partner closely with investigative sites, and collaborate with project teams to deliver high-quality, inspection-ready clinical trials. What You’ll Do - Perform site monitoring activities (on-site and remote) using a risk-based monitoring approach - Ensure protocol, ICH-GCP, regulatory, and SOP compliance at investigator sites - Conduct SDR, SDV, CRF review, and investigational product accountability - Identify, document, escalate, and follow up on issues through resolution, applying root cause analysis and CAPA principles - Maintain audit and inspection readiness at all assigned sites - Build strong, collaborative relationships with investigators and site staff - Document monitoring activities in timely, high-quality reports and follow-up letters - Maintain ongoing communication with sites between visits to support issue resolution and data quality - Ensure study systems (e.g., CTMS) are updated according to study conventions - Provide trial status updates and metrics to the Clinical Team Manager (CTM) - Support study start-up, investigator identification, site initiation, and study close-out activities as assigned - Participate in investigator meetings, audits, inspections, and project team meetings as required Additional responsibilities may include supporting process improvement initiatives, mentoring activities, or project-specific tasks aligned with experience. A Day in the Life - Review site metrics and prioritize monitoring activities based on risk - Conduct on-site or remote monitoring visits - Partner with sites to resolve findings and improve processes - Collaborate with CTMs and project teams to keep studies on track and inspection-ready - Complete documentation, system updates, and administrative tasks Education & Experience - Bachelor’s degree in a life sciences related field or equivalent qualification - Minimum 2+ 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.