Senior CRA I/II - Senior Klinischer Monitor (m/w/d) (Chemiker/in)
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.
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)
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
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.
Job available in 5 locations: Remote, Hamburg, Berlin, Frankfurt, Munich Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description About Us
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.
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