Clinical Study Data Excellence Lead (all genders)

<p><span style="font-family: verdana, geneva, sans-serif;">YOUR ROLE:</span></p><p> </p><p><span style="font-family: verdana, geneva, sans-serif;">As our Clinical Study Data Excellence Lead, you’ll own end-to-end Clinical Study Data Management across R&D, coordinating work by CROs, FSPs, and vendors. This Director-level role defines and continuously improves 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.</span></p><p> </p><p><span style="font-family: verdana, geneva, sans-serif;">WHO YOU ARE:</span></p><p> </p><ul type="disc"><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">15+ years in clinical development operations, clinical data management, or clinical quality within pharma, biotech, or CRO settings.</span></li><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">Experienced as an Operational Excellence Lead, Business Process Owner, or Quality/Compliance Lead with SOP authorship, process governance, audits/inspections, and continuous improvement.</span></li><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">Possess deep knowledge of ICH GCP (E6(R3)), regulatory requirements, and trial frameworks (CDISC, TransCelerate).</span></li><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">Expert in process measurement, KPI dashboards, performance reporting, CAPA governance, and GxP compliance.</span></li><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">Have strong grasp of clinical data management systems (EDC, data review benches, central data monitoring, digital workflow tools).</span></li><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">You tailor messages for contributors, stakeholders, and leaders, able to communicate across all levels.</span></li><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">Influence without formal authority; build consensus and align with vendors and senior teams.</span></li><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">Future-focused; you identify automation and digital opportunities to boost quality and scalability.</span></li></ul><p><span style="font-family: verdana, geneva, sans-serif;">YOUR MAIN BENEFITS:</span></p><ul type="disc"><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card </span></li><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">Work-Life balance: Enjoy additional paid days off, flexible working hours.</span></li><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities</span></li><li style="font-family: verdana, geneva, sans-serif;"><span style="font-family: verdana, geneva, sans-serif;">Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection.</span></li></ul><p><span style="font-family: verdana, geneva, sans-serif;"> Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Portal.</span></p><p> </p>