Clinical Data Excellence Director: Process, QA & Automation

Biopharma Careers; Warszawa; On-site; PLN 420,000 - 640,000; Full time

Benefits offered by this job

Private medical care

Life insurance

Sports card

Prepaid lunch card

Flexible working hours

Extra paid days off

Language courses support

Training and certifications

Employee Assistance Program

Job summary

Biopharma Careers is seeking a Director-level Clinical Data Management professional to own governance of data processes across in-house functions, CROs, and vendor partnerships. You will define and continuously improve process standards, controls, KPIs, quality documents, and training to ensure inspection-ready, GxP-compliant practices aligned with ICH GCP (E6(R3)).

You’ll drive automation and digital enablement to boost quality and scalability, serve as the primary process expert during audits,

Qualifications

• 15+ years in clinical development operations, data management, or quality in pharma/CRO.
• Experience as Operational Excellence Lead or Quality/Compliance Lead with SOPs and audits.
• Deep knowledge of ICH GCP (E6(R3)) and regulatory trial frameworks (CDISC, TransCelerate).
• Expertise in KPI measurement, dashboards, CAPA governance, and GXP compliance.
• Strong experience with clinical data management systems (EDC, data review benches, central data monitoring, digital workflows).

Responsibilities

• Define and continuously improve process standards, controls, KPIs, quality documents, and training.
• Serve as the primary process expert during audits and inspections.
• Partner with R&D, IT, vendors, BPOs, and senior leaders to embed a culture of process excellence, innovation, and risk-based decision-making.
• Drive automation and digital enablement to boost quality, efficiency, and scalability.

Skills

Operational leadership

Process governance

KPI dashboards

GxP compliance

Communication skills

Automation opportunities

Tools

EDC systems

Data review benches

Central data monitoring

Digital workflow tools

Job description

Biopharma Careers is seeking a Director-level Clinical Data Management professional to own governance of data processes across in-house functions, CROs, and vendor partnerships. You will define and continuously improve process standards, controls, KPIs, quality documents, and training to ensure inspection-ready, GxP-compliant practices aligned with ICH GCP (E6(R3)).

You’ll drive automation and digital enablement to boost quality and scalability, serve as the primary process expert during audits,