Job available in 5 locations: Berlin, Hamburg, Munich, Frankfurt, 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., Senior CRA, 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

This position is for experienced Clinical Research Associates with 2+ years of independent monitoring experience. You will manage clinical trial sites across Germany, ensuring studies are conducted in compliance with the protocol, ICH-GCP, applicable regulations, and company SOPs.

You’ll work autonomously, partner closely with investigative sites, and collaborate with project teams to deliver high-quality, inspection-ready clinical trials.


## What You’ll Do


- Perform site monitoring activities (on-site and remote) using a risk-based monitoring approach

- Ensure protocol, ICH-GCP, regulatory, and SOP compliance at investigator sites

- Conduct SDR, SDV, CRF review, and investigational product accountability

- Identify, document, escalate, and follow up on issues through resolution, applying root cause analysis and CAPA principles

- Maintain audit and inspection readiness at all assigned sites

- Build strong, collaborative relationships with investigators and site staff

- Document monitoring activities in timely, high-quality reports and follow-up letters

- Maintain ongoing communication with sites between visits to support issue resolution and data quality

- Ensure study systems (e.g., CTMS) are updated according to study conventions

- Provide trial status updates and metrics to the Clinical Team Manager (CTM)

- Support study start-up, investigator identification, site initiation, and study close-out activities as assigned

- Participate in investigator meetings, audits, inspections, and project team meetings as required


Additional responsibilities may include supporting process improvement initiatives, mentoring activities, or project-specific tasks aligned with experience.


## A Day in the Life


- Review site metrics and prioritize monitoring activities based on risk

- Conduct on-site or remote monitoring visits

- Partner with sites to resolve findings and improve processes

- Collaborate with CTMs and project teams to keep studies on track and inspection-ready

- Complete documentation, system updates, and administrative tasks


###


## Education & Experience


- Bachelor’s degree in a life sciences related field or equivalent qualification

- Minimum 2+ 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.*