About this role
Job available in 4 locations: Munich, Berlin, Hamburg, Remote
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.*