Senior Clinical Research Associate (Sr CRA) / Senior Klinischer Monitor – Full-Time or Part-Time Available (m/w/d)
- Company: Thermo Fisher Scientific
- Location: Remote, Germany
- Work mode: Remote
- Job type: Full-Time
- Posted: 2026-07-23
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.
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