Global Trial Acceleration Associate

About the Role

This individual contributor role has task-level responsibility for clinical trial related document collection, compilation, review and approval across all phases of global clinical trials. This may also include review of all the Site Monitoring Visit reports, issue escalation, resolution and follow up tasks.

Key Responsibilities

• Managing and executing centralized activities in support of global trials with an emphasis on clinical documentation.
• Interacting with clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitors (CTMo.), the study team and other functional areas within BMS and providing support to the Study Team throughout the study duration (start-up, maintenance, and close-out of clinical studies).
• As the main point of contact for essential document management, ethical and regulatory submission-related activities, developing and maintaining collaborative working relationships with relevant stakeholders.
• Supporting outsourcing activities by interfacing with operational teams, support groups and service providers for successful selection, contracting and execution of outsourced studies while ensuring compliance with regulatory standards, ethical practices, BMS outsourcing and procurement policies and procedures.
• Initiating and managing start-up documentation activities for global clinical trials.
• Submission of potential investigators to CTSS for debarment review and tracking of decisions.
• Responsible for country/Site Activation for clinical trials as applicable per region; this includes the final review of applicable documents, final sign-off of the country/site activation checklist. May also be responsible for activating the site in accordance with all applicable global / local study procedures.
• Providing a level of quality control of start-up activity.
• Updating and reviewing various study-related clinical systems to determine and report status of clinical trial documents for insourced studies (i.e., CTMS, eTMF, or corresponding vendor systems).
• Arranging certified translation of study level documentation from translators as requested (i.e., ICF, Protocol, IB).
• Assisting with the coordination or creation of other study-specific materials such as pharmacy or Investigator site file to ensure that these are available on site for site initiation visits/prior to first patient visit.
• Acting as a single point of contact for the study team for centralized activities during study start-up.
• Ongoing maintenance and tracking of essential documentation and collection of updated/outstanding documentation and submission as required during all phases of clinical trial.
• Ongoing communication with study teams regarding centralized study activities.
• Responsible for the creation and management of standardized document templates.
• Assisting with CSR distribution.
• Country and site level ICF adaptation.
• Essential document collection, review and approval of country and site level documents.
• Centrally reviewing all the Site Monitoring Visit reports, issue escalation, resolution and follow up tasks.
• Other duties as assigned to support Clinical Trials.

Requirements & Tech Stack

• CTMS
• eTMF
• ICF
• CSR

Qualifications

• We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.