Lead cra / lead monitor

Job Title: Lead Clinical Research Associate (Lead CRA / Lead Monitor) Location: Germany (home-based / hybrid) Department: Clinical Operations Overview An 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 Responsibilities Study Oversight & Monitoring Act as Lead CRA on Phase I-IV clinical trials Perform and oversee on-site and remote monitoring visits (SIV, IMV, COV) Ensure compliance with ICH-GCP, SOPs, and regulatory requirements Proactively identify and manage site risks, deviations, and quality issues Leadership & Coordination Provide guidance and oversight to CRAs across assigned studies Mentor junior CRAs and support onboarding and development Ensure consistency and quality of monitoring deliverables Study Management Partner closely with Project Managers and cross-functional teams Support feasibility, site selection, and site start-up activities Review monitoring documentation and ensure audit readiness Sponsor & Stakeholder Management Act as a key interface with a multinational pharmaceutical sponsor Build strong relationships with investigators and study sites Contribute to sponsor communication and study reporting Requirements Bachelor's degree in Life Sciences or related discipline 5 years of CRA experience , including lead or mentoring responsibilities Strong knowledge of ICH-GCP and European clinical trial regulations Experience working on multinational clinical trials Fluent in German and English (both required) Strong communication and stakeholder management skills Willingness to travel (~20-40%) What's on Offer Competitive salary bonus Home-based flexibility across Germany Direct exposure to global pharma-sponsored trials Clear career progression (e.g., CTM / PM pathway) Opportunity to join a rapidly expanding CRO with global ambitions