Job available in 4 locations: Hamburg, Remote, Berlin, Munich

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. 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
Serve as a trusted partner to investigative sites, sponsors, and internal project teams
Identify trends across sites and studies and provide strategic recommendations to the Clinical Team Manager (CTM)
Ensure accurate and timely updates of study systems (e.g. CTMS) and perform QC reviews where required
Participate in investigator meetings and support investigator identification and feasibility activities
Support investigator payment processes and trial financial oversight as applicable

Leadership, Mentorship & Process Improvement

Actively mentor, coach, and support the development of junior and senior CRAs
Contribute to project-specific and functional training initiatives
Identify opportunities for process optimization and drive implementation of improvements
Provide expert input into monitoring strategies and clinical operations best practices

Administrative & Operational Responsibilities

Maintain timely and accurate completion of timesheets, expense reports, and required documentation
Maintain frequent communication with sites between visits to ensure ongoing compliance and issue resolution
Drive corrective and preventive actions (CAPAs) to resolution and proactively mitigate risk
Author high-quality monitoring reports and follow-up correspondence in a timely manner
Act as a key escalation point for significant site issues, protocol deviations, and compliance risks
Support and lead activities related to audits, inspections, and regulatory inquiries

Education & Experience

Bachelor’s degree in a life sciences related field or equivalent qualification
Minimum 5+ 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.
Schwerbehinderte Bewerberinnen und Bewerber werden bei gleicher Eignung bevorzugt berücksichtigt.

Principal CRA – Lead Monitor (m/w/d)