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

• Manage and execute centralized activities in support of global trials with an emphasis on clinical documentation.
• Interact with clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitors (CTMo.), the study team and other functional areas within BMS.
• Provide support to the Study Team throughout the study duration (start-up, maintenance, and close-out of clinical studies).
• Act as the main point of contact for essential document management and ethical and regulatory submission-related activities.
• Develop and maintain collaborative working relationships with relevant stakeholders.
• Support outsourcing activities by interfacing with operational teams, support groups and service providers for successful selection, contracting and execution of outsourced studies.
• Ensure compliance with regulatory standards, ethical practices, BMS outsourcing and procurement policies and procedures.
• Initiate and manage start-up documentation activities for global clinical trials.
• Submit potential investigators to CTSS for debarment review and track decisions.
• Responsible for country/Site Activation for clinical trials as applicable per region.
• This includes the final review of applicable documents and final sign-off of the country/site activation checklist.
• May be responsible for activating the site in accordance with all applicable global / local study procedures.
• May provide a level of quality control of start-up activity.
• Update and review of various study-related clinical systems (e.g., CTMS, eTMF, or corresponding vendor systems) to determine and report status of clinical trial documents for insourced studies.
• May arrange certified translation of study-level documentation from translators as requested (e.g., ICF, Protocol, IB).
• May assist with the coordination or creation of other study-specific materials such as pharmacy or Investigator site files to ensure they are available on site for site initiation visits/prior to first patient visit.
• May act 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.
• May be responsible for creation and management of standardized document templates.
• Assist with CSR distribution.
• Country and site-level ICF adaptation.
• Essential document collection, review and approval of country and site-level documents.
• Centrally review all Site Monitoring Visit reports, issue escalation, resolution and follow-up tasks.
• Other duties as assigned to support Clinical Trials.

Requirements & Tech Stack

• Clinical documentation management.
• Site Monitoring Visit reports review, issue escalation, resolution, and follow-up.
• Interaction with clinical study sites, CROs/vendors, CTM/CTMo, study team, and other functional areas.
• Support for study start-up, maintenance, and close-out phases.
• Experience in essential document management and ethical/regulatory submission-related activities.
• Experience supporting outsourcing activities.
• Experience with country/site activation for clinical trials.
• Experience updating and reviewing clinical systems like CTMS and eTMF.
• Experience with certified translation of study-level documentation.
• Experience coordinating or creating study-specific materials for site initiation.
• Experience managing essential documentation throughout clinical trial phases.
• Experience with CSR distribution.
• Experience with ICF adaptation at country and site levels.
• Proficiency in centralized activities during study start-up.

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.