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
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