Global Trial Acceleration Associate

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Working with Us Challenging. Meaningful. Life-changing. Those are not words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You will get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary 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 The Global Trial Acceleration Associate is responsible for managing and executing on centralized activities in support of global trials with an emphasis on clinical documentation. The Global Trial Acceleration Associate will interact with clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitor (CTMo.), the study team and other functional areas within BMS and will provide 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, develops and maintains 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 while ensuring compliance with regulatory standards, ethical practices, BMS outsourcing and procurement policies and procedures. Initiate and manage 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. The incumbent may also 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 to determine and report status of clinical trial documents for insourced studies (i.e., CTMS, eTMF, etc. or corresponding vendor systems) May arrange certified translation of study level documentation from translators as requested (i.e., ICF, Protocol, IB) May assist 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. May act as 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. Maybe 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 reviewing all the Site Monitoring Visit reports, issue escalation, resolution and follow up tasks. Other duties as assigned to support Clinical Trials. Qualifications & Experience Minimum of a bachelor’s degree in legal, Life science, Business Administration, or equivalent experience. Advanced degree a plus. Minimum 3 years of relevant clinical development & operational experience in Pharmaceutical, biotech, CRO or similar fields, is required. Seasoned field monitor with min 3+ years of global site monitoring (Clinical Research Associate) report review experience is preferred. Prior therapeutic area expertise (eg: Oncology, Cardiology, Hematology, Immunology etc) is preferred. Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies; including formulating responses to queries. Hands-on experience of preparing, reviewing, and submitting clinical study start-up / activation documentation, including responses to queries. Knowledge of IC