Expert eClinical Systems Consultant

1 week ago

Pune, Maharashtra, India beBeeClinicalAnalyst Full time ₹ 15,00,000 - ₹ 20,00,000
Job Title

This role is responsible for managing and maintaining eClinical systems to ensure accuracy and completeness of clinical trials.

The successful candidate will work on multiple projects, collaborating with clients to develop, maintain, and close out clinical trials using various eClinical systems.

  • Key Responsibilities:
  • Create and complete billable quality reviews to ensure document content and metadata application are accurate and complete.
  • Perform periodic quality reviews for regulatory documents, including IRB Renewal, IRB Protocol Approval, Informed Consent Review, and Signature of Co-Investigator.
  • Complete regulatory document review and compilation of documents for FDA submissions using GCP and ICH guidelines.
  • Develop and implement TMF Quality plans and reports, and reconcile findings.
  • Communicate systematic filing issues to the manager for further evaluation.
  • Work with Study Owners on start-up, maintenance, and closeout activities related to the TMF.
  • eTMF ongoing user management.
  • Assume responsibility for creating and maintaining events/placeholders in the eTMF as needed.
  • Identify and report TMF trending issues/concerns to Study Owner, Clinical Document Lead, Project Manager, Client, and/or Manager, determining resolutions and course of action.
  • Provide support on metrics and report preparation for TMF Key Performance Indicators (KPIs) – completeness, quality, and timeliness.
  • Storyboard support and maintenance to assist with inspection readiness.
  • CTMS data entry and analysis on behalf of CTMS and enterprise clients.

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