Senior Data Standards Expert — Hybrid CRF & CDISC Lead

Merck Healthcare; Warszawa; On-site; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Private medical care

Life insurance

Sports card

Lunch card

Additional paid days off

Flexible working hours

Language courses support

Training and certifications support

Job summary

Merck Healthcare in Warsaw seeks a Senior Data Standards Expert / CRF Designer to shape and maintain clinical data standards and design high-quality electronic case report forms for global clinical studies. You will lead complex study builds, manage metadata and standards libraries, and ensure/CDISC/CDASH/SDTM alignment while mentoring colleagues.

The role requires collaboration across clinical data management, programming, regulatory and technology teams, with on-site work in Warsaw for 3 days

Qualifications

• 6-8 years in clinical data standards, data management or eDC design.
• Strong CDISC, CDASH, SDTM, metadata and CRF design expertise.
• Experience leading complex studies and cross-functional projects.
• Knowledge of regulatory submissions and validation tools.
• Clear communication, problem-solving and mentoring skills.

Responsibilities

• Shape and maintain clinical data standards and design high-quality electronic case report forms for global clinical studies.
• Lead complex study builds in electronic data capture systems and manage metadata and standards libraries.
• Ensure alignment with CDISC, CDASH and SDTM requirements and oversight of external partners.
• Support submission readiness and manage study-level standards exceptions.
• Mentor colleagues and drive improvements in standards governance, automation and data formats.

Skills

CDISC/CDASH/SDTM expertise

CRF design

data standards governance

mentoring & leadership

regulatory submissions knowledge

Education

Advanced degree in life sciences or computer science

Job description

Merck Healthcare in Warsaw seeks a Senior Data Standards Expert / CRF Designer to shape and maintain clinical data standards and design high-quality electronic case report forms for global clinical studies. You will lead complex study builds, manage metadata and standards libraries, and ensure/CDISC/CDASH/SDTM alignment while mentoring colleagues.

The role requires collaboration across clinical data management, programming, regulatory and technology teams, with on-site work in Warsaw for 3 days