Principal CRA - Lead 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. 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

We are seeking a highly experienced Principal Clinical Research Associate (CRA) to lead and coordinate all aspects of clinical monitoring and site management for complex clinical trials. Acting as a subject-matter expert and site process specialist, you will ensure trials are conducted in accordance with the approved protocol, ICH-GCP, applicable regulatory requirements, and internal SOPs-ensuring subject safety, data integrity, and continuous audit readiness. In this principal-level role, you will manage complex and high-risk studies across multiple sponsor and monitoring models (e.g. FSO, FSP, government-sponsored research). You will serve as a key escalation point for sites and project teams, take a leadership role on assigned studies, and actively contribute to the mentoring and development of junior and senior CRAs alike.

What You'll Do

Principal-Level Clinical Monitoring & Oversight

+ Lead monitoring activities for complex, high-risk, or strategically important clinical trials using a risk-based monitoring approach

+ Independently conduct on-site and remote monitoring visits in line with approved monitoring plans

+ Perform and oversee SDR, SDV, and CRF review, ensuring the highest standards of data accuracy and integrity

+ Evaluate investigational product accountability through physical inventory and records review

+ Ensure essential documents are complete, inspection-ready, and compliant with ICH-GCP and applicable German/EU regulations

+ Lead site initiation, maintenance, and close-out activities, providing expert guidance and recommendations

Quality, Risk & Issue Management

+ Apply advanced root cause analysis (RCA), critical thinking, and problem-solving methodologies to identify systemic site issues

+ Strategic Project & Stakeholder Collaboration