Senior CRA I/II - Senior Klinischer Monitor (m/w/d)

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-