Job highlights

- 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.

Work Your Magic with us! Ready to explore, break barriers, and discover more. We'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 cutting-edge 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 3 days per week.

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, manage metadata and standards libraries, and ensure alignment with CDISC, CDASH and SDTM requirements.
- Oversee standards deliverables from external partners, support submission readiness, manage study-level standards exceptions, and apply quality-by-design principles.
- Work across clinical data management, programming, regulatory and technology teams, mentor colleagues and drive improvements in standards governance, automation and emerging data formats.
- This role requires being on-site in our office 3 days per week.

Requirements

- 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Data Standards Expert (all genders) (Bengaluru)
🏢 Merck
📍 Bengaluru