Principal CRA – Lead 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. 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>We are seeking a highly experienced Principal Clinical Research Associate (CRA) to lead and coordinate all aspects of clinical monitoring and site management for complex clinical trials. Acting as a subject-matter expert and site process specialist, you will ensure trials are conducted in accordance with the approved protocol, ICH-GCP, applicable regulatory requirements, and internal SOPs—ensuring subject safety, data integrity, and continuous audit readiness.</p><p>In this principal-level role, you will manage complex and high-risk studies across multiple sponsor and monitoring models (e.g. FSO, FSP, government-sponsored research). You will serve as a key escalation point for sites and project teams, take a leadership role on assigned studies, and actively contribute to the mentoring and development of junior and senior CRAs alike.</p><p></p><h2>What You’ll Do</h2><h2></h2><h2><b>Principal-Level Clinical Monitoring &amp; Oversight</b></h2><ul><li><p>Lead monitoring activities for complex, high-risk, or strategically important clinical trials using a risk-based monitoring approach</p></li><li><p>Independently conduct on-site and remote monitoring visits in line with approved monitoring plans</p></li><li><p>Perform and oversee SDR, SDV, and CRF review, ensuring the highest standards of data accuracy and integrity</p></li><li><p>Evaluate investigational product accountability through physical inventory and records review</p></li><li><p>Ensure essential documents are complete, inspection-ready, and compliant with ICH-GCP and applicable German/EU regulations</p></li><li><p>Lead site initiation, maintenance, and close-out activities, providing expert guidance and recommendations</p></li></ul><p></p><p><b>Quality, Risk &amp; Issue Management</b></p><ul><li><p>Apply advanced root cause analysis (RCA), critical thinking, and problem-solving methodologies to identify systemic site issues</p></li><li><p>Strategic Project &amp; Stakeholder Collaboration</p></li><li><p>Serve as a trusted partner to investigative sites, sponsors, and internal project teams</p></li><li><p>Identify trends across sites and studies and provide strategic recommendations to the Clinical Team Manager (CTM)</p></li><li><p>Ensure accurate and timely updates of study systems (e.g. CTMS) and perform QC reviews where required</p></li><li><p>Participate in investigator meetings and support investigator identification and feasibility activities</p></li><li><p>Support investigator payment processes and trial financial oversight as applicable</p></li></ul><p></p><p><b>Leadership, Mentorship &amp; Process Improvement</b></p><ul><li><p>Actively mentor, coach, and support the development of junior and senior CRAs</p></li><li><p>Contribute to project-specific and functional training initiatives</p></li><li><p>Identify opportunities for process optimization and drive implementation of improvements</p></li><li><p>Provide expert input into monitoring strategies and clinical operations best practices</p></li></ul><p></p><p><b>Administrative &amp; Operational Responsibilities</b></p><ul><li><p>Maintain timely and accurate completion of timesheets, expense reports, and required documentation</p></li><li><p>Maintain frequent communication with sites between visits to ensure ongoing compliance and issue resolution</p></li><li></li><li><p>Drive corrective and preventive actions (CAPAs) to resolution and proactively mitigate risk</p></li><li><p>Author high-quality monitoring reports and follow-up correspondence in a timely manner</p></li><li><p>Act as a key escalation point for significant site issues, protocol deviations, and compliance risks</p></li><li><p>Support and lead activities related to audits, inspections, and regulatory inquiries</p></li></ul><p></p><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>5</b><b><b>&#43; </b>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>