Senior Data Standards Expert - CRF Designer (Warsaw On-Site)

Emd Group; Warszawa; On-site; PLN 140,000 - 190,000; Full time

Benefits offered by this job

Private medical care

Life insurance

Sports card

Lunch card

Extra paid days off

Flexible hours

Language course funding

Training & certs

Employee Assistance Program

Engagement groups

Job summary

Emd Group in Warsaw is seeking a Senior Data Standards Expert / CRF Designer to shape and maintain clinical data standards and design high-quality electronic case report forms for global studies.

You will lead complex study builds in electronic data capture systems, manage metadata, ensure CDISC/CDASH/SDTM alignment, oversee external partners, support submissions, and mentor colleagues while driving governance improvements.

Qualifications

• Advanced degree in life sciences or computer science with relevant experience.
• 6–8 years in clinical data standards, data management or eDC design.
• Strong knowledge of CDISC standards and CRF design.
• Experience leading complex studies and cross-functional projects.
• Familiarity with regulatory submissions and validation tools.

Responsibilities

• Shape and maintain clinical data standards and design high-quality electronic case report forms for global studies.
• Lead complex study builds in electronic data capture systems (eDC).
• Manage metadata and standards libraries, ensuring CDISC/CDASH/SDTM alignment.
• Oversee standards deliverables from external partners and support submission readiness.
• Mentor colleagues and drive improvements in standards governance, automation and data formats.

Skills

CDISC/CDASH/SDTM

CRF design

Data standards

Cross-functional leadership

Regulatory submissions knowledge

Education

Advanced degree in life sciences or computer science

Job description

Emd Group in Warsaw is seeking a Senior Data Standards Expert / CRF Designer to shape and maintain clinical data standards and design high-quality electronic case report forms for global studies.

You will lead complex study builds in electronic data capture systems, manage metadata, ensure CDISC/CDASH/SDTM alignment, oversee external partners, support submissions, and mentor colleagues while driving governance improvements.