Domain SME (Clinical Standards & Digital Data Flow Leader)

Experience: 8+ Years

Location: PAN India

CTC: Up to 40 LPA

Industry: Life Sciences / Pharma / CRO

Key Responsibilities

- Provide subject matter expertise in Clinical Standards and Digital Data Flow to support product and solution development.
- Define and contribute to strategic positioning and roadmap for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics and Data Management solutions.
- Support the development of differentiated solutions and product offerings for the Pharma and Life Sciences industry.
- Provide business and domain expertise for solutions involving SDTM, ADaM, TFLs, EDC, SDR, USDM and regulatory submission packages.
- Identify opportunities for automation, AI and innovative technologies across clinical data standardization and submission processes.
- Support strategy for generating EDC builds from study protocols and implementing SDR/USDM models.
- Drive innovative approaches to testing, validation and quality control.




- Support customer presentations, RFI/RFP responses and go-to-market strategies.
- Contribute to thought leadership through industry articles, webinars, conferences and advisory forums.
- Build and maintain solid relationships with senior stakeholders, Pharma organizations, CROs and industry partners.
- Represent the organization in relevant industry forums and standards organizations such as CDISC, TransCelerate and IMI.

Key Areas of Expertise

- Clinical Data Standards and CDISC frameworks
- SDTM, ADaM and regulatory submission packages
- Digital Data Flow and Clinical Data Flow strategy
- Metadata Repository
- Biometrics and Clinical Data Management
- EDC, non-CRF data and eDTA
- TFL development and regulatory reporting
- SDR Model and USDM

Interested candidates can share their updated CV at [HIDDEN TEXT] & [HIDDEN TEXT]

📌 Domain SME (Secunderabad)
🏢 Latinum Hr Solutions
📍 Secunderabad