Principal Clinical Research Associate (PCRA) / Klinischer Monitor – Full-Time or Part-Time Available (m/w/d)

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.
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