Smitha Hegadi

About Smitha Hegadi

Over a decade of experience in clinical data management. Member of SCDM skilled in Clinical Data Management; Medical Data Review and Inspection readiness.Performing CDM activities viz. EDC/ database build, eCRF design, Edit checks, UAT, Validation, Discrepancy Management, SAE, Central Lab, IVRS and other Vendor reconciliations, SAS listing review, Medical Review, etc. with Advanced Diploma in Clinical Research and Medical degree from Rajiv Gandhi University of Health Sciences.

Experience

1. Lead Clinical Data Manager

   Kapadi

   Aug 2023 — Present · US

   Perform full-spectrum CDM activities for multiple (Phase I - global studies, overseeing study build, eCRF design, edit checks specifications, UAT, data validation, data cleaning, and database lock.• EDC Development, writing EDC Specifications.• Responsible for the collection, processing, and quality control of clinical trial data. Manage data review and cleaning activities.• Author and maintain CRFs, DMPs, CCGs, Data Transfer Agreement/Specifications, Data Validation Plans and other study documents to ensure alignment with study objectives and regulatory standards.• Create & provide Metrics for internal and sponsor requirements.• Lead data transfers and exchange activities with vendors and data sharing networks. • SAE Reconciliation.• Supervise and mentor Clinical Data Coordinators and other data management team members.• Successfully managed EDC start-up and go-live for multiple studies, delivering all milestones on schedule and within scope.• Collaborated cross-functionally with database programmers, statisticians, coding, and clinical teams to maintain data accuracy and quality.• Manage third-party data vendors (central labs, IRT), define and implement data transfer specifications (DTS), ensuring timely and compliant data integration.• Oversee generation of study-specific and ad hoc reports; track data metrics and ensure audit-ready eTMF documentation.• Represent CDM in Study Management Team meetings; Present deliverables and updates during sponsor calls, served as the primary point of contact for sponsors and internal stakeholders. • Support risk identification and mitigation, change management, and budget adherence across projects.• Contribute to process optimization initiatives and support proposal development and scope definition. Play a key role in strategic planning and technology adoption within the biometrics team, driving innovation and efficiency.

Education

• Clinotek India

  Adv. Dip. in Clinical Research, Pharmacovigilance, Clinical Data Management and Medical Writing, Clinical Research

  2012 — 2012

• Rajiv Gandhi University of Health Sciences

  BHMS

• Rajiv Gandhi University of Health Sciences

  Bachelor of Homoeopathic Medicine and Surgery, Medicine

• Karnataka University

  PGDYS