Senior CRA I/II - Senior Klinischer Monitor (m/w/d)

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><h2>About Us</h2><p>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.</p><p></p><p>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.</p><p></p><h2>Why Join Thermo Fisher Scientific / PPD?</h2><ul><li><p>Work on high-quality, global clinical trials across diverse therapeutic areas</p></li><li><p>Be part of a stable, well-established organization with long-term career opportunities</p></li><li><p>Strong collaboration with experienced CTMs and project teams</p></li><li><p>Clear development pathways (e.g., Senior CRA, Lead CRA, CTM)</p></li><li><p>Flexible working models that support work-life balance</p></li><li><p>Permanent employment</p></li><li><p>Full-time (40 hours/week) or Part-time (32 hours/week) options available</p></li></ul><p></p><h2>About the Role</h2><p>This position is for experienced Clinical Research Associates with 2&#43; 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.</p><p>You’ll work autonomously, partner closely with investigative sites, and collaborate with project teams to deliver high-quality, inspection-ready clinical trials.</p><p></p><h2>What You’ll Do</h2><ul><li><p>Perform site monitoring activities (on-site and remote) using a risk-based monitoring approach</p></li><li><p>Ensure protocol, ICH-GCP, regulatory, and SOP compliance at investigator sites</p></li><li><p>Conduct SDR, SDV, CRF review, and investigational product accountability</p></li><li><p>Identify, document, escalate, and follow up on issues through resolution, applying root cause analysis and CAPA principles</p></li><li><p>Maintain audit and inspection readiness at all assigned sites</p></li><li><p>Build strong, collaborative relationships with investigators and site staff</p></li><li><p>Document monitoring activities in timely, high-quality reports and follow-up letters</p></li><li><p>Maintain ongoing communication with sites between visits to support issue resolution and data quality</p></li><li><p>Ensure study systems (e.g., CTMS) are updated according to study conventions</p></li><li><p>Provide trial status updates and metrics to the Clinical Team Manager (CTM)</p></li><li><p>Support study start-up, investigator identification, site initiation, and study close-out activities as assigned</p></li><li><p>Participate in investigator meetings, audits, inspections, and project team meetings as required</p></li></ul><p>Additional responsibilities may include supporting process improvement initiatives, mentoring activities, or project-specific tasks aligned with experience.</p><p></p><h2>A Day in the Life</h2><ul><li><p>Review site metrics and prioritize monitoring activities based on risk</p></li><li><p>Conduct on-site or remote monitoring visits</p></li><li><p>Partner with sites to resolve findings and improve processes</p></li><li><p>Collaborate with CTMs and project teams to keep studies on track and inspection-ready</p></li><li><p>Complete documentation, system updates, and administrative tasks</p></li></ul><h3></h3><h2><b>Education &amp; Experience</b></h2><ul><li><p>Bachelor’s degree in a life sciences related field or equivalent qualification</p></li><li><p>Minimum <b>2&#43; years of experience as a Clinical Research Associate / Monitor</b></p></li><li><p>Valid driver’s license</p></li><li><p>Full right to work in Germany</p></li><li><p><b>Fluency in German and English (C1 level)</b> – interviews will be conducted in German</p></li></ul><p></p><p><b>Knowledge, Skills &amp; Abilities</b></p><ul><li><p>Strong clinical monitoring skills with hands-on RBM experience</p></li><li><p>Excellent understanding and application of ICH-GCP and applicable regulations</p></li><li><p>Solid therapeutic area knowledge and medical terminology</p></li><li><p>Well-developed critical thinking, problem-solving, and root cause analysis skills</p></li><li><p>Strong written and verbal communication skills with medical professionals</p></li><li><p>High attention to detail and strong organizational skills</p></li><li><p>Ability to work independently while contributing effectively to cross-functional teams</p></li><li><p>Flexibility and adaptability in a dynamic project environment</p></li><li><p>Proficiency in Microsoft Office and ability to learn clinical systems (e.g., CTMS)</p></li></ul><h2></h2><p><b>Locations:</b> Home-based or hybrid anywhere in Germany<br /><b>FTE:</b> Full-time (40 hrs/week) or Part-time 80% (32 hrs/week)<br /><b>Contract:</b> Permanent<br /><b>Travel:</b> Approximately 50–75% (study-dependent)</p><p></p><p><i>Severely disabled applicants with the same aptitude will be given preferential treatment.<br />Schwerbehinderte Bewerberinnen und Bewerber werden bei gleicher Eignung bevorzugt berücksichtigt.</i></p><p></p><p></p><p></p><p></p><p></p>