Senior CRA III Senior Klinischer Monitor (mwd)

Work Schedule

Environmental Conditions

Job Description

About Us

At Thermo Fisher Scientific youll 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.

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

What Youll 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

• Bachelors degree in a life sciences related field or equivalent qualification

• Minimum 2 years of experience as a Clinical Research Associate / Monitor

• Valid drivers 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 5075% (study-dependent)

Severely disabled applicants with the same aptitude will be given preferential treatment.
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