Domain SME

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