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