Senior CRA I/II - Senior Klinischer Monitor (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., 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.
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