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

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., Senior CRA, 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 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 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 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 in timely, high-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 in investigator meetings, audits, 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 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.Originally posted on Himalayas

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., Senior CRA, 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 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 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 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 in timely, high-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 in investigator meetings, audits, 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 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.Originally posted on Himalayas