Lead CRA / Lead Monitor M/W/D

Job Title: Lead Clinical Research Associate (Lead CRA / Lead Monitor)Location: Germany (home-based / hybrid)Department: Clinical OperationsOverviewAn expanding international CRO is seeking an experienced Lead CRA / Lead Monitor to support the growth of its global clinical operations.This role will play a key part in the delivery of international clinical trials and will work closely with a leading multinational pharmaceutical sponsor, providing strong exposure to large-scale, high-impact studies.The position combines hands-on monitoring with leadership responsibility and offers clear progression within a fast-growing organization.Key ResponsibilitiesStudy Oversight & MonitoringAct as Lead CRA on Phase I-IV clinical trialsPerform and oversee on-site and remote monitoring visits (SIV, IMV, COV)Ensure compliance with ICH-GCP, SOPs, and regulatory requirementsProactively identify and manage site risks, deviations, and quality issuesLeadership & CoordinationProvide guidance and oversight to CRAs across assigned studiesMentor junior CRAs and support onboarding and developmentEnsure consistency and quality of monitoring deliverablesStudy ManagementPartner closely with Project Managers and cross-functional teamsSupport feasibility, site selection, and site start-up activitiesReview monitoring documentation and ensure audit readinessSponsor & Stakeholder ManagementAct as a key interface with a multinational pharmaceutical sponsorBuild strong relationships with investigators and study sitesContribute to sponsor communication and study reportingRequirementsBachelor's degree in Life Sciences or related discipline5+ years of CRA experience, including lead or mentoring responsibilitiesStrong knowledge of ICH-GCP and European clinical trial regulationsExperience working on multinational clinical trialsFluent in German and English (both required)Strong communication and stakeholder management skillsWillingness to travel (~20-40%)What's on OfferCompetitive salary + bonusHome-based flexibility across GermanyDirect exposure to global pharma-sponsored trialsClear career progression (e.g., CTM / PM pathway)Opportunity to join a rapidly expanding CRO with global ambitions