Thermo Fisher / PPD
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
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
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.
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.
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
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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