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

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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.
Schwerbehinderte Bewerberinnen und Bewerber werden bei gleicher Eignung bevorzugt berücksichtigt.*