Global Trial Acceleration Associate

Overview

Individual contributor role with task-level responsibility for clinical trial document collection, compilation, review and approval across all phases of global clinical trials, including review of Site Monitoring Visit reports and issue escalation.

What you'll do

• Manage and execute centralized activities in support of global trials with an emphasis on clinical documentation.
• Act as main point of contact for essential document management and ethical and regulatory submission-related activities.
• Interact with clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitors (CTMo), the study team and other functional areas within BMS.
• Support outsourcing activities by interfacing with operational teams, support groups and service providers for selection, contracting and execution of outsourced studies while ensuring compliance with regulatory standards, ethical practices, and BMS outsourcing and procurement policies.
• Initiate and manage start-up documentation activities for global clinical trials.
• Submit potential investigators to CTSS for debarment review and track decisions.
• Be responsible for country/site activation for clinical trials as applicable per region, including final review of applicable documents and final sign-off of the country/site activation checklist.
• Possibly activate sites in accordance with applicable global/local study procedures and provide a level of quality control of start-up activity.
• Update and review study-related clinical systems (e.g., CTMS, eTMF or vendor systems) to determine and report status of clinical trial documents for insourced studies.
• Arrange certified translation of study-level documentation (e.g., ICF, Protocol, IB) as requested.
• Assist with coordination or creation of study-specific materials such as pharmacy or Investigator site files.
• Act as single point of contact for the study team for centralized activities during study start-up.
• Maintain and track essential documentation, collect updated/outstanding documentation and submit as required across all phases of the trial.
• Communicate with study teams regarding centralized study activities.
• Possibly create and manage standardized document templates.
• Assist with CSR distribution and country and site-level ICF adaptation.
• Collect, review and approve essential country and site-level documents.
• Centrally review all Site Monitoring Visit reports, escalate issues, and handle resolution and follow-up tasks.
• Perform other duties as assigned to support Clinical Trials.

Details

• Location: Hyderabad, Telangana, India.
• Requisition number R1603866.
• Work model is assigned based on core responsibilities (site-essential, site-by-design, field-based or remote-by-design).