Clinical Study Data Excellence Lead (all genders)

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.