Overview
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.
Verantwortungsbereiche
- 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
Zentrale Anforderungen
- 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
Project Manager - Phase I - Germany in Osnabrück Arbeitgeber: Syneos Health
Syneos Health ist ein hervorragender Arbeitgeber, der sich leidenschaftlich für die Entwicklung seiner Mitarbeiter einsetzt und eine inklusive Unternehmenskultur fördert, in der jeder authentisch sein kann. Mit einem starken Fokus auf Karriereentwicklung, technische Schulungen und Anerkennung bietet das Unternehmen zahlreiche Möglichkeiten zur persönlichen und beruflichen Entfaltung. In Nordostdeutschland gelegen, profitieren Mitarbeiter von einem dynamischen Arbeitsumfeld, das Innovation und Zusammenarbeit fördert, um gemeinsam bedeutende Fortschritte im Gesundheitswesen zu erzielen.
