Senior Data Standards Expert (all genders)

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

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

In your role as Senior Data Standards Expert / CRF Designer (all genders), you will shape and maintain clinical data standards and design high-quality electronic case report forms for global clinical studies. You will lead complex study builds in electronic data capture systems, manage metadata and standards libraries, and ensure alignment with CDISC, CDASH and SDTM requirements. You will oversee standards deliverables from external partners, support submission readiness, manage study-level standards exceptions, and apply quality-by-design principles. Working across clinical data management, programming, regulatory and technology teams, you will mentor colleagues and drive improvements in standards governance, automation and emerging data formats.

This role requires to be on-site in our office in Warsaw, Poland for 3 days per week.

Who You Are

• Advanced degree in life sciences, computer science or equivalent experience
• 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

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.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!