About The RoleThis 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 -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 DoPerform site monitoring activities (on-site and remote) using a risk-based monitoring approachEnsure protocol, ICH-GCP, regulatory, and SOP compliance at investigator sitesConduct SDR, SDV, CRF review, and investigational product accountabilityIdentify, document, escalate, and follow up on issues through resolution, applying root cause analysis and CAPA principlesMaintain audit and inspection readiness at all assigned sitesBuild strong, collaborative relationships with investigators and site staffDocument monitoring activities h-quality reports and follow-up lettersMaintain ongoing communication with sites between visits to support issue resolution and data qualityEnsure study systems (e.g., CTMS) are updated according to study conventionsProvide 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 assignedParticipate its, inspections, and project team meetings as requiredAdditional responsibilities may include supporting process improvement initiatives, mentoring activities, or project-specific tasks aligned with experience.A Day in the LifeReview site metrics and prioritize monitoring activities based on riskConduct on-site or remote monitoring visitsPartner with sites to resolve findings and improve processesCollaborate with CTMs and project teams to keep studies on track and inspection-readyComplete documentation, system updates, and administrative tasksEducation & ExperienceBachelor’s degree in a life sciences related field or equivalent qualificationMinimum 2 + 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 English & 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)About 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 goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.Why Jot of Thermo Fisher Scientific?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., Senior CRA, Lead CRA, CTM)Flexible working models that support work-life balancePermanent employmentFull-time (40 hours/week)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, 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, 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 – InvolvementIf 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!
3 days ago