Clinical Study Data Excellence Lead (all genders)
Merck Healthcare
Πλήρης απασχόληση
Αθήνα
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.
This role requires to be on-site in our office in Maroussi, Greece for 3 days per week.
Your Role
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.
Who You Are
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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.
This role requires to be on-site in our office in Maroussi, Greece for 3 days per week.
Your Role
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.
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.
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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