Senior Clinical Research Associate (Sr CRA) / Senior 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., 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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