Sanjana Shashikanth

Key Responsibilities & Achievements

• Velsera is a health tech company delivering advanced software products and expert services to accelerate the discovery, development, and delivery of precision medicine globally.
• Clinical Product Design & UAT
  Contributed to clinical product design and user acceptance testing (UAT) in collaboration with design engineers and knowledgebase leads, supporting the adoption of the AI tool (SWIFT). Identified and implemented process improvements to reduce manual efforts and enhance operational efficiency.
• Backlog Management & Agile Planning of sprint
  Prioritized curation projects to ensure timely data uploads while deferring lower-priority tasks. Led sprint planning sessions for clinical trial data pipeline initiatives.
• Defect Resolution & Risk Management
  Led defect triage and root cause analysis (RCA), driving corrective and preventive actions (CAPA). Collaborated cross-functionally to resolve client queries and mitigate operational risks.
• Regulatory Compliance & QA Collaboration
  Ensured ISO 13485 compliance by partnering with software quality assurance (SQA) and regulatory teams. Applied SDLC principles to support monthly software releases, maintaining compliance and delivery consistency.
• Risk & Safety Analysis
  Experienced in conducting Software Hazard Analysis (SHA) to support safe and compliant AI tool adoption.

• Clinical Interpretation Services
  Supported clinical interpretation services by analyzing genomic variants and contributing to the generation of accurate, actionable clinical reports in alignment with internal guidelines and medical relevance.
• Clinical Trials Biocuration
  Transitioned into clinical trials biocuration, curating and integrating trial data into internal knowledgebase to support precision medicine insights and therapeutic matching.
• Data Quality & Process Improvement
  Implemented process improvements to streamline data curation workflows and reduce redundancy. Played a key role in cleaning and validating curated data, enhancing data integrity and accuracy.