Clinical Study Data Excellence Lead (all genders)

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

Your role:

If you are a seasoned Clinical Data Management professional ready to own process excellence at scale, this Director-level role will put you at the center of R&D's data management governance - spanning in-house execution, CROs, FSPs, and vendor partnerships. As our Clinical Study Data Excellence Lead, you will define and continuously improve 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

Your main benefits:

• Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card
• Work-Life balance: Enjoy additional paid days off, flexible working hours
• Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities
• Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection

Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Portal