The businesses of Merck KGaA, Darmstadt, Germany
Associate Director Clinical Data Manager (all genders)
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Your role
As a senior team member within Clinical Data Management, you will lead the end-to-end data management delivery for assigned global Phase I–IV clinical trials or a defined study portfolio, with a particular focus on complex oncology, neurology or immunology development. You will set the strategic direction for data collection, cleaning, review, reconciliation, and quality activities, ensuring the accuracy, integrity, completeness, and submission-readiness of clinical trial data. Operating with a high degree of autonomy, you will serve as the primary Clinical Data Management representative at the study/program level, providing operational expertise and aligning cross-functional and global teams in a matrix organization.
You will implement risk-based data management and data-flow strategies for in-house and outsourced studies, identify opportunities to apply automation, advanced analytics, and AI-enabled solutions to improve data quality and study execution, oversee CRO/vendor delivery, and support Health Authority submission activities by providing data management expertise and reviewing relevant materials. Beyond your study portfolio, you will actively shape the future of the function through process improvement initiatives, contributing to SOPs and best-practice workstreams, knowledge sharing, and mentoring colleagues to strengthen Clinical Data Management capability across the organization.
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Who you are
You hold a Bachelor’s or Master’s degree in a scientific or technical discipline — life sciences, data management, or a related field. You have at least 10 years of experience in clinical data management within the pharmaceutical, biotechnology, or healthcare industry, including substantial leadership of complex oncology, neurology, or immunology trials at study and program level. You bring deep expertise in end-to-end data management, including risk-based data collection and cleaning strategies, eCRF design, external data management, and coding, with strong knowledge of CDISC, CDASH, and SDTM standards.
You have a proven track record of managing CRO/vendor relationships, including operational performance oversight and budget monitoring, and are experienced in in-house sourcing models. You are skilled at leading and coordinating global, cross-functional teams in a matrix environment, and are confident providing updates on study progress, financials, forecasts, risks, issues, and timelines to senior stakeholders. You demonstrate strong project management capabilities — planning study timelines and resources, identifying and mitigating risks, resolving issues, and managing multiple priorities simultaneously with a high degree of independence.
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You are committed to continuous improvement and bring external insights to contribute to innovation, process development, and the evolution of data management standards and SOPs. Experience with Risk Based Data Monitoring and Management is preferred. Experience evaluating or implementing automation and/or AI-enabled innovations in clinical data management, with an understanding of data quality, traceability, validation, human oversight, and compliance considerations, is an advantage.
Location
This role requires to be on-site in our office in Feltham for 3 days per week.
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