Project Manager - Phase I - Germany

In this role you lead Phase I clinical projects for a single sponsor, ensuring on-time study delivery within budget and regulatory guidelines. You act as the primary liaison between the sponsor and our company, coordinating cross-functional teams to achieve study milestones. You’ll drive quality, risk management, and data integrity across GMP/GCP-compliant studies, shaping project plans and client relationships. This opportunity puts you at the center of fast-moving clinical development, with impact on patient outcomes and therapeutic delivery.

• Lead cross-functional project delivery for interdisciplinary clinical studies, ensuring GCP, SOPs, and regulatory compliance
• Serve as primary liaison with the customer to secure timely study launch, conduct, and closeout per contracts
• Guide project team to meet quality, timelines, and budget targets; own financial performance
• Coordinate study conduct partners, proactively identify and mitigate issues
• Ensure TMF completeness and maintain study data across databases and systems
• Oversee study management components for inspection readiness
• Develop and implement project plans, risk mitigation, and contingency strategies
• Plan, coordinate, and present at internal and external meetings; prepare PM reports for clients and management
• Foster client relationships to generate new or add-on business; participate in bid defense meetings
• Potentially line-manage junior PMs and clinical monitoring staff

• Bachelor’s Degree in life sciences or equivalent; CRO experience preferred
• Previous PM experience in Clinical Research; Phase I experience is essential
• Strong knowledge of Good Clinical Practice/ICH and regulatory requirements
• Excellent organizational, time management, and independent work abilities
• Strong communication, presentation, and interpersonal skills
• Willingness to travel approximately 25%
• Ability to embrace new technologies

• strong communication
• interpersonal skills
• problem-solving
• GCP/ICH regulatory knowledge
• budgeting and financial management
• risk management and contingency planning