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Global harmonization of clinical trial monitoring and site management, integrating digital health technologies. 12+ years of clinical research experience required. Preparing for and responding to regulatory inspections, adapting to decentralized and risk-based monitoring.
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Anforderungen
- Advanced degree in Life Sciences, Medicine, Clinical Research, or related field, or equivalent professional experience
- 12+ years of experience in clinical research, with deep expertise in site management and clinical monitoring across global environments
- Proven track record of owning end-to-end clinical processes, including process design, documentation, performance oversight, and continuous improvement in a regulated setting
- Highly knowledgeable in ICH-GCP guidelines, including ICH E6(R3), and experienced in applying Quality by Design and risk-based quality management principles
- Led cross-functional initiatives in complex matrix organizations, building alignment across diverse teams, CROs, and vendors without direct authority
- Partnered with technology and digital teams to shape system requirements and drive adoption of tools that support process compliance and operational efficiency
- Strong analytical and data-driven approach to translate performance metrics into targeted process improvements
- Comfortable in a global, multicultural setting and willing to travel internationally up to 20% of the time
Aufgaben
- Drive excellence in clinical trial monitoring and site management
- Ensure global harmonization of clinical monitoring practices
- Prepare for and respond to regulatory inspections
- Adapt to evolving trial models, including decentralized and risk-based monitoring
- Integrate digital health technologies into site management
- Define and implement clinical monitoring strategies
- Coordinate site activation, initiation, monitoring, and close-out
- Manage ongoing site oversight, escalation, and issue resolution
- Link site management activities to CAPA processes
- Ensure clear communication and role clarity across functions
- Align site-facing engagement with GDO and R&D peers
- Collaborate with Regional and Cluster Heads on process implementation
- Partner with study teams, CROs, and vendors for effective site management
- Shape and implement GCP-compliant clinical monitoring processes
- Align processes with regulatory expectations and organizational goals
- Support modern clinical trial delivery needs
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