Clinical Data Excellence Lead — Flexible Hours

Merck Healthcare; Warszawa; On-site; PLN 420,000 - 660,000; Full time

Job summary

Merck Healthcare seeks a Director-level Clinical Study Data Excellence Lead to own end-to-end Clinical Study Data Management across R&D, coordinating CROs, FSPs, and vendors. The role defines process standards, KPIs, and training to ensure inspection-ready, GxP-compliant processes aligned with ICH GCP (E6(R3)).

You will drive automation and digital enablement to boost quality, efficiency, and scalability. You will partner with R&D, IT, vendors, and senior leaders to embed a culture of process

Qualifications

• 15+ years in clinical development operations, clinical data management, or clinical quality in pharma, biotech, or CRO settings.
• Operational Excellence Lead or similar with SOPs, governance, audits/inspections, and continuous improvement.
• Deep knowledge of ICH GCP (E6(R3)), regulatory requirements, and trial frameworks (CDISC, TransCelerate).
• Expert in KPI dashboards, performance reporting, CAPA governance, and GxP compliance.
• Proficient with clinical data management systems (EDC, data review benches, central data monitoring, digital workflows).

Responsibilities

• Own end-to-end Clinical Study Data Management across R&D.
• Coordinate work by CROs, FSPs, and vendors.
• Define and improve SOPs, controls, KPIs, and training for inspection readiness.
• Drive automation and digital enablement to boost quality and scalability.

Skills

Clinical development operations

Clinical data management

Quality/compliance leadership

Process governance

KPI dashboards

GxP compliance

ICH GCP E6(R3)

Regulatory requirements

Stakeholder communication

Vendor management

Tools

EDC systems

Central data monitoring

Digital workflow tools

Job description

Merck Healthcare seeks a Director-level Clinical Study Data Excellence Lead to own end-to-end Clinical Study Data Management across R&D, coordinating CROs, FSPs, and vendors. The role defines process standards, KPIs, and training to ensure inspection-ready, GxP-compliant processes aligned with ICH GCP (E6(R3)).

You will drive automation and digital enablement to boost quality, efficiency, and scalability. You will partner with R&D, IT, vendors, and senior leaders to embed a culture of process