CRA II/Sr CRA - Sponsor-Dedicated FSP - Germany (m/f/d)

## About the Role

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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

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## 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 English & 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)

Contract: Permanent

Travel: Approximately 50–75% (study-dependent)

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At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an [award-winning learning and development programme](https://www.ppdi.com/careers/about#Training), ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a [flexible working culture](https://www.ppdi.com/careers/life-at-ppd), where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application - we’d love to hear from you!

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

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

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Quelle: Statistisches Bundesamt (Destatis), Tabelle; dl-de/by-2-0; eigene Berechnung