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Head of Data Standards & CRF Design
Bangalore, Karnataka, India
Actively hiring, first seen by us 3 days ago- Pay
- Pay not listed
- Work setting
- Not stated
- Employment
Full-time — employment source
Employment type in the employer’s posting: Full-time
From the employer’s posting
What you’ll work on
Full postingLead a global team on clinical data standards, CRF design, and metadata governance
Own the operational implementation of CRF, SDTM, and non-CRF domain standards
Drive governance and version control in the metadata repository
Ensure eDC CRF design and SDTM submission readiness for outsourced studies
From the employer’s posting
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
ensure high-quality study design, eDC CRF Design, and regulatory submission readiness fpr SDTM packages in outsourced studies
What you’ll bring
All qualificationsCore experience
- 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 proven experience in CRF design, eDC study build standards, metadata repository lifecycle management, external data standards, and regulatory submission readiness.
Preferred experience
- 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.
Qualification wording
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 proven experience in CRF design, eDC study build standards, metadata repository lifecycle management, external data standards, and regulatory submission readiness.
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.
Posting record
Report an errorActively hiringFirst seen by us 3 days ago, still listed, and not a repost of an earlier posting.
- Status in our records
- Live
- First seen by us
- Nov 10, 20263 days ago
- Recorded sightings
- 4
- Last seen by us
- Nov 13, 2026
- Employer says posted
- Oct 28, 2026
These dates show when we found the posting. Check the employer’s website to confirm it is still accepting applications.
How this job compares
Emdgroup is hiring
30 open jobs
Open jobs by the week we first saw them, last 12 weeks.
Hiring recordSee how this role fits your experience
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Your next step
Complete your application on careers.emdgroup.com. The employer’s form will show what is required.
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Demand for Data Leadership roles
New Data Leadership postings at the employers we follow are about the same over the last 6 weeks compared with the 6 before.
Each bar is one week of new postings. The darkest bars are the last 6 weeks.
Counted from the hiring pages we’ve followed for at least five weeks, so employers we add don’t look like growth. Updated weekly.
About the role
We file this job under Data Leadership, by the work the posting describes.
Data leaders run data teams or design how a company's data fits together. Managers hire, set priorities and answer for whether the data work pays off; architects choose the systems and the shape of the data.
Expect years of hands-on data work, experience leading people or projects, and the ability to explain tradeoffs to executives.
Unlike a senior engineer or analyst, most of a data leader's week goes to people, planning and decisions rather than building.
US government figures for computer and information systems managers
- Median yearly pay, May 2025
- $175,140
- Expected change, 2025 to 2035
- 15.8% more jobsagainst 3.5% for all jobs
The government has no code for data leaders, so these figures are for the closest group, computer and information systems managers, which includes data processing and data operations managers.
Source: US Bureau of Labor Statistics, Occupational Employment and Wage Statistics (May 2025) and Employment Projections (2025 to 2035). Occupation code 11-3021.
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!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Source details
Source notes
Source excerptsSelected passages from the saved posting. Check the full description for conditions and exceptions.
- Pay
No pay amount identified in the saved description.
- Location & working pattern
Bangalore, Karnataka, India
Working pattern and location restrictions need checking in the full posting.
- Work authorization
No clear work-authorization passage found. Eligibility is unconfirmed.