Etmf Specialist

Overview

Manage and execute centralized activities supporting global clinical trials, with emphasis on clinical documentation quality and eTMF inspection readiness.

What you'll do

• Upload and perform rigorous quality reviews of electronic documents residing in the eTMF system to ensure they are inspection-ready and compliant with ALCOA Plus principles.
• Apply filing attributes and metadata to documents to facilitate classification, management, identification and retrieval.
• Provide immediate feedback for any quality issue findings.
• Interact with regional roles, the study team and other functional areas within BMS to manage document quality, timeliness and completeness.
• Support the study team throughout the study duration (start-up, maintenance and close-out of clinical studies).
• Develop and maintain collaborative working relationships with clinical study teams.
• Review essential regulatory documentation, including submission of final documents to the eTMF.
• Provide a level of quality control of start-up activities.
• Act as single point of contact for the study team for centralized activities related to document management.
• Maintain and track essential records and collect updated or outstanding documentation.
• Proactively resolve issues related to missing or expired documents.
• Communicate ongoing with study teams regarding centralized document management activities.
• Perform other duties as assigned to support Clinical Trials.

Details

• Location: Hyderabad, Telangana, India.
• Work model is assigned based on core responsibilities (site-essential, site-by-design, field-based or remote-by-design); details at careers.bms.com/ways-of-working.