TCS is Hiring for

Role : Clinical Standards & Digital Data Flow Leader(Domain SME)

Experience: 10 - 15 Years

Location: Pan India

Requirement
Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage
10+ years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs)
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
Experience in creative ways to automate testing and validation
Robust stakeholder engagement and communication skills
Background in Pharma, Biotech, or CRO organizations





Roles & Responsibilities
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.
Drive collaboration between business stakeholders and implementation teams to ensure successful solution delivery.

Thanks & Regards

Babeeta Shahi

📌 Domain Sme Mumbai
🏢 Tata Consultancy Services
📍 Mumbai