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Clinical Study Data Excellence Lead (all genders)

merckgroup

📅 04/08/2026
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Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your role: If you are a seasoned Clinical Data Management professional ready to own process excellence at scale, this Director-level role will put you at the center of R&D's data management governance - spanning in-house execution, CROs, FSPs, and vendor partnerships. As our Clinical Study Data Excellence Lead, you will define and continuously improve process standards, controls, KPIs, quality documents, and training to ensure inspection-ready, GxP-compliant processes aligned with ICH GCP (E6(R3)). You’ll drive automation and digital enablement to boost quality, efficiency, and scalability, and serve as the primary process expert during audits and inspections. You’ll read the room, facilitate conversations with higher management, and act as a proactive project sponsor - proposing actionable strategies to address the problem statements. Partner with R&D, IT, vendors, BPOs, and senior leaders to embed a culture of process excellence, innovation, and risk-based decision-making. Who you are: 15+ years in clinical development operations, clinical data management, or clinical quality within pharma, biotech, or CRO settings Experienced as an Operational Excellence Lead, Business Process Owner, or Quality/Compliance Lead with SOP authorship, process governance, audits/inspections, and continuous improvement Possess deep knowledge of ICH GCP (E6(R3)), regulatory requirements, and trial frameworks (CDISC, TransCelerate) Expert in process measurement, KPI dashboards, performance reporting, CAPA governance, and GxP compliance Have strong grasp of clinical data management systems (EDC, data review benches, central data monitoring, digital workflow tools) You tailor messages for contributors, stakeholders, and leaders, able to communicate across all levels Influence without formal authority; build consensus and align with vendors and senior teams Future-focused; you identify automation and digital opportunities to boost quality and scalability Your main benefits: Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card Work-Life balance: Enjoy additional paid days off, flexible working hours Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Portal What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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