Clinical Site Management Excellence Lead (all genders)
The businesses of Merck KGaA, Darmstadt, Germany · GB
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About the Role
The Clinical Site Management Excellence Lead is a strategic and operational leader responsible for driving excellence in clinical trial monitoring and site management. This role ensures global harmonization, inspection readiness, and responsiveness to evolving trial models like decentralized trials and risk-based monitoring.
Responsibilities
- Drive excellence in planning, execution, and oversight of clinical trial monitoring and site management activities.
- Ensure clinical monitoring and site management practices are globally harmonized, inspection-ready, and responsive to evolving trial models.
- Define how site management enables effective implementation of clinical monitoring strategy.
- Coordinate interactions between different functions and study sites at country, regional, and global levels.
- Ensure clear communication, role clarity, aligned site-facing engagement, and consistent ways of working.
- Shape and implement scalable, efficient, and GCP-compliant clinical monitoring and site management processes.
- Partner with technology and digital teams to shape system requirements and drive adoption of tools.
- Apply a strong analytical and data-driven approach to translate performance metrics into targeted process improvements.
Requirements
- 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 globally.
- 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).
- 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.
- Comfortable in a global, multicultural setting.
Skills
- Clinical monitoring strategy
- Site activation
- Site initiation
- Site monitoring
- Ongoing oversight
- Escalation
- Issue management
- CAPA linkage
- Site close-out
- Cross-functional initiative leadership
- Process design
- Process documentation
- Performance oversight
- Continuous improvement
- ICH-GCP guidelines
- Quality by Design
- Risk-based quality management
- Analytical approach
- Data-driven approach
- Communication
- Collaboration
Location
- Feltham, UK
Work Type
- On-site
- Hybrid
Experience Level
- 12+ years
Education Level
- Advanced degree
Benefits
- Opportunities for personal development
- Career advancement opportunities
About the Company
- Colleagues across the globe innovate with science and technology to enrich people’s lives in Healthcare, Life Science, and Electronics.
- The company dreams big and is passionate about caring for its diverse mix of people, customers, patients, and planet.
- The Healthcare purpose is to help create, improve and prolong lives by developing medicines, intelligent devices and innovative technologies.
- Teams work together across 6 continents with passion and relentless curiosity.
- The company fosters a diverse, inclusive and flexible working culture.
- The company is committed to creating access and opportunities for all to develop and grow.
- The company aims to build a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.