Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAbout UsAt 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 areasBe part of a stable, well-established organization with long-term career opportunitiesStrong collaboration with experienced CTMs and project teamsClear development pathways (e.g. Lead CRA, CTM)Flexible working models that support work-life balancePermanent employmentFull-time (40 hours/week) or Part-time (32 hours/week) options availableAbout the RoleWe 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.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.What You’ll DoPrincipal-Level Clinical Monitoring & OversightLead monitoring activities for complex, high-risk, or strategically important clinical trials using a risk-based monitoring approachIndependently conduct on-site and remote monitoring visits in line with approved monitoring plansPerform and oversee SDR, SDV, and CRF review, ensuring the highest standards of data accuracy and integrityEvaluate investigational product accountability through physical inventory and records reviewEnsure essential documents are complete, inspection-ready, and compliant with ICH-GCP and applicable German/EU regulationsLead site initiation, maintenance, and close-out activities, providing expert guidance and recommendationsQuality, Risk & Issue ManagementApply advanced root cause analysis (RCA), critical thinking, and problem-solving methodologies to identify systemic site issuesStrategic Project & Stakeholder CollaborationServe as a trusted partner to investigative sites, sponsors, and internal project teamsIdentify trends across sites and studies and provide strategic recommendations to the Clinical Team Manager (CTM)Ensure accurate and timely updates of study systems (e.g. CTMS) and perform QC reviews where requiredParticipate in investigator meetings and support investigator identification and feasibility activitiesSupport investigator payment processes and trial financial oversight as applicableLeadership, Mentorship & Process ImprovementActively mentor, coach, and support the development of junior and senior CRAsContribute to project-specific and functional training initiativesIdentify opportunities for process optimization and drive implementation of improvementsProvide expert input into monitoring strategies and clinical operations best practicesAdministrative & Operational ResponsibilitiesMaintain timely and accurate completion of timesheets, expense reports, and required documentationMaintain frequent communication with sites between visits to ensure ongoing compliance and issue resolutionDrive corrective and preventive actions (CAPAs) to resolution and proactively mitigate riskAuthor high-quality monitoring reports and follow-up correspondence in a timely mannerAct as a key escalation point for significant site issues, protocol deviations, and compliance risksSupport and lead activities related to audits, inspections, and regulatory inquiriesEducation & ExperienceBachelor’s degree in a life sciences related field or equivalent qualificationMinimum 5+ years of experience as a Clinical Research Associate / MonitorValid driver’s licenseFull right to work in GermanyFluency in German and English (C1 level) – interviews will be conducted in GermanKnowledge, Skills & AbilitiesStrong clinical monitoring skills with hands-on RBM experienceExcellent understanding and application of ICH-GCP and applicable regulationsSolid therapeutic area knowledge and medical terminologyWell-developed critical thinking, problem-solving, and root cause analysis skillsStrong written and verbal communication skills with medical professionalsHigh attention to detail and strong organizational skillsAbility to work independently while contributing effectively to cross-functional teamsFlexibility and adaptability in a dynamic project environmentProficiency in Microsoft Office and ability to learn clinical systems (e.g., CTMS)Locations: Home-based or hybrid anywhere in GermanyFTE: Full-time (40 hrs/week) or Part-time 80% (32 hrs/week)Contract: PermanentTravel: Approximately 50–75% (study-dependent)Severely disabled applicants with the same aptitude will be given preferential treatment.Schwerbehinderte Bewerberinnen und Bewerber werden bei gleicher Eignung bevorzugt berücksichtigt.