Rekha Thomas

About Rekha Thomas

CAREER SUMMARY Exceptionally organized person with efficient Project…

Experience

1. Global Regulatory Study Start up Specialist

   Galderma

   Aug 2024 — Present · CA, US

   Supports study startup and IRB activities, including but not limited to obtaining andmaintaining Essential documents, regulatory and ethics approvals.• Manage site and study startup, maintenance and closeout activities across pharmaceutical (RX) and medical device (AX) trials, optimizing timelines and regulatory adherence.• Supports creation of startup plans and essential documents checklists for assigned studies• Prepare Country EC submission package. • Supports the development of country-specific ICFs• Creates essential document packages to sites and checks for completion• Supports site submissions to Central IRBs • Confirms greenlight for site activation• Participates in study team meetings and provides start up status and IRB approval updates• Provides IRB guidance to ensure compliance with applicable regulations and requirements• Supports study teams during internal study audits and/or other process improvement activities• Supports in-house regulatory submission to Regulatory Agencies(FDA Annual Report)• Supports study teams for and/or during mock and actual inspections by regulatory authorities• Manage PI Debarment checks• Maintain ED status tracker, ICF log, IRB Tracker• Ensure milestones were correctly entered in CTMS • Track and assess TMF health and report metrics throughout the study in alignment with the TMF plan, identifying and documenting quality issues, while implementing solutions and resolving concerns as needed.• Support the development of work instructions for study startup activities and IRB submission processes, ensuring clarity, accuracy, and compliance with regulatory guidelines.• Assist in establishing and managing study milestones within CTMS, ensuring accurate tracking and alignment with study timelines.• Create and implement study-related templates, tracking tools, and FAQs, ensuring standardized processes and streamlined study management.• Supports Photo collection project by drafting ICF and IRB submission

Education

• Northwestern University

  Master's degree

  2015 — 2017

• SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES,COLLEGE OF PHARMACY (Inst. Code - 030), COIMBATORE

  Bachelor's degree

  2002 — 2007