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Clinical Site Management Excellence Lead (all genders)

EMD Serono / MilliporeSigma / Merck · Pharmaceuticals & Biotechnology & Life Sciences
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<p><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><strong>This role requires to be on-site in our office in Eysins, Switzerland for 3 days per week.</strong></span></p><p> </p><p><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><strong>Your role:</strong></span></p><p><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">The <strong>Clinical Site Management Excellence Lead</strong> is a strategic and operational leader responsible for driving excellence in the planning, execution, and oversight of clinical trial monitoring and site management activities. The role is pivotal in ensuring that clinical monitoring and site management practices are globally harmonized, inspection-ready, and responsive to evolving trial models, including decentralized trials, risk-based monitoring, remote and centralized monitoring, digital health integration, and evolving site-facing coordination needs.</span></p><p><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">With clinical monitoring strategy as a core focus, the role also defines how site management enables effective implementation of that strategy in practice,  from site activation and initiation through site monitoring, ongoing oversight, escalation, issue management, CAPA linkage, and close-out. Site management in this context also includes the coordination of how different functions interact with study sites at country, regional/cluster, and global levels, ensuring clear communication, role clarity, aligned site-facing engagement, and consistent ways of working across GDO and R&D peers, Regional and Cluster Heads, study teams, CROs, vendors, and other functions interfacing with sites.</span></p><p><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">As an internal consultant and transformation leader, the Site Management Excellence Lead partners closely with Regional and Cluster Heads, GDO peers, applicable study members, and site-facing functions to shape and implement scalable, efficient, and Good Clinical Practice (GCP)-compliant clinical monitoring and site management processes. These processes must align with regulatory expectations, organizational objectives, and the needs of modern clinical trial delivery.</span></p><p> </p><p> </p><p><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><strong>Who you are</strong></span></p><ul><li style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">You hold an advanced degree in Life Sciences, Medicine, Clinical Research, or a related field, or bring equivalent professional experience.</span></li><li style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">You bring 12+ years of experience in clinical research, with deep expertise in site management and clinical monitoring across global environments.</span></li><li style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">You have a proven track record of owning end-to-end clinical processes, including process design, documentation, performance oversight, and continuous improvement in a regulated setting.</span></li><li style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">You are highly knowledgeable in ICH-GCP guidelines, including ICH E6(R3), and experienced in applying Quality by Design and risk-based quality management principles.</span></li><li style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">You have led cross-functional initiatives in complex matrix organizations, building alignment across diverse teams, CROs, and vendors without direct authority.</span></li><li style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">You have partnered with technology and digital teams to shape system requirements and drive adoption of tools that support process compliance and operational efficiency.</span></li><li style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">You apply a strong analytical and data-driven approach to translate performance metrics into targeted process improvements.</span></li><li style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;"><span style="font-family: verdana, geneva, sans-serif; font-size: 10.0pt;">You are comfortable in a global, multicultural setting and willing to travel internationally up to 20% of the time.</span></li></ul>