Principal Clinical Research Associate (PCRA) / Klinischer Monitor – Full-Time or Part-Time Available (m/w/d)
- Company: Thermo Fisher Scientific
- Location: Remote, Germany
- Work mode: Remote
- Job type: Full-Time
- Posted: 2026-07-23
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
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* 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.
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