Head of Data Standards & CRF Design

Merck Healthcare; Bengaluru; On-site; INR 3,500,000 - 7,500,000; Full time

Job summary

Merck Healthcare is seeking a Director of Clinical Data Standards and CRF Design to lead a global team responsible for data standards, CRF design, and metadata governance across trial programs. You will drive SDTM implementation, ensure regulatory submission readiness, and collaborate with clinical, data management, and IT stakeholders to enable high-quality data delivery.

The role involves partnering with CROs and vendors, advancing new standards, and promoting a culture of change and

Qualifications

• Advanced degree in Life Sciences, Data Science, Information Systems, Computer Science, or equivalent.
• 10+ years in clinical data standards within pharma/biotech/CRO environments, with senior leadership progression.
• 5+ years leading global, multidisciplinary data standards teams.
• Deep expertise in CDISC standards and submission deliverables: CDASH, SDTM, Define.xml, aCRF, SDRG, inspection-ready governance.
• Experience in CRF design, eDC study build standards, metadata repository lifecycle, external data standards, regulatory submission readiness.
• Strong governance, risk management, vendor/CRO partnerships, and cross-functional decision-making in regulated settings.
• Experience with emerging standards/tech like Dataset-JSON, SDTM v3.0, CDISC Open Rules, ICH M11, HL7 FHIR-CDISC interoperability, AI-enabled metadata automation is a plus.
• Strong executive communication and stakeholder influence.

Responsibilities

• Lead a global team accountable for clinical data standards, CRF design, and metadata governance.
• Own operational implementation of standards across CRF, SDTM, and non-CRF domains.
• Drive governance and version control in the metadata repository.
• Ensure high-quality study design, eDC CRF design, and regulatory submission readiness.
• Partner with Clinical Development, Data Management, Biostatistics, Safety, Regulatory, IT, CROs, and vendors to advance standards and digital innovation.
• Champion inspection readiness and data-standards modernization across the organization.

Skills

CDISC standards

CRF design

metadata governance

data standards

Regulatory submission

stakeholder influence

executive communication

change leadership

vendor collaboration

cross-functional leadership

Education

Advanced degree in Life Sciences / Data Science / IS / CS

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 Director, Clinical Data Standards and CRF Design, you will lead a global team accountable for clinical data standards, CRF design, metadata governance, and submission-ready data deliverables. You will own the operational implementation of standards across CRF, SDTM, and non-CRF domains, drive governance and version control in the metadata repository, and ensure high-quality study design, eDC CRF Design, and regulatory submission readiness fpr SDTM packages in outsourced studies. You will partner across Clinical Development, Data Management, Biostatistics, Safety, Regulatory, IT, CROs, technology vendors, and industry forums to advance standards, inspection readiness, and digital innovation.This is a highly collaborative global role where your leadership directly impacts how fast we bring life-changing solutions to patients. You will find excellent opportunities to grow your career as you lead change and champion clinical data innovation across the organization.

Who You Are

• You hold an advanced degree in Life Sciences, Data Science, Information Systems, Computer Science, or an equivalent scientific or technical discipline.


• You bring 10 or more years of progressive experience in clinical data standards within a pharmaceutical, biotech, or CRO environment, including demonstrated progression into senior leadership roles.


• You have at least 5 years of experience leading and developing global, multidisciplinary teams responsible for data standards definition, implementation, and cross-functional integration.


• You possess deep expertise in CDISC standards and submission-related deliverables, including CDASH, SDTM, Define.xml, annotated CRF (aCRF), SDRG, and inspection-ready metadata governance.


• You have proven experience in CRF design, eDC study build standards, metadata repository lifecycle management, external data standards, and regulatory submission readiness.


• You demonstrate a strong track record in governance, quality oversight, risk management, vendor and CRO partnership, and cross-functional decision-making in a regulated clinical development environment.


• Experience with emerging standards and technologies such as Dataset-JSON, SDTM v3.0, CDISC Open Rules, ICH M11, HL7 FHIR-to-CDISC interoperability, or AI-enabled metadata and protocol-to-CRF automation is a plus.


• Strong executive communication, stakeholder influence, change leadership, and the ability to represent the function in external standards or industry forums are advantageous.

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!