TCS is hiring for

Role: Clinical Standards & Digital Data Flow Leader

Location: Delhi, Noida

Qualification
Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage

Skills
Extensive hands-on experience and Expertise with Digital Data Flow, data collection standards, biostatistical programming SDTM, ADaM, TFLs, Regulatory Submissions, EDC, and Metadata Management
Experience in applying AI in standardization, SDTM, ADaM and TFL generation.
Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM

Job Responsibility
Contributes in building Product and solutions in Digital Data Flow by providing Subject Matter expertise and knowledge on Industry Trends.




Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.)
Co-leads the design & development for these solutions from a business view
Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships.

Thanks & Regards

Babeeta Shahi

TCS – HR

📌 Domain Sme Noida
🏢 Tata Consultancy Services
📍 Noida