Senior Global Trial Acceleration Associate

Responsibilities

• The Senior Global Trial Acceleration Associate is responsible for managing and executing on centralized activities in support of global trials with an emphasis on clinical documentation.
• As the main point of contact for essential document management, ethical and regulatory submission-related activities, develops and maintains collaborative working relationships with clinical investigator sites.
• Initiate and manage start-up documentation activities for global clinical trials:
• Submission of potential investigators to CTSS for debarment review and tracking of decisions.
• Review of essential regulatory documentation and interaction with sites to resolve outstanding issues, including submission of final documents to the electronic Trial Master File (eTMF)
• 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)
• Arrange certified translation of study level documentation from translators as requested (i.e., IC, 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.
• 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 to Regulatory as required.
• Managing all correspondence sent to investigative sites (i.e., IB updates, protocol amendments) and working with the sites to obtain IRB/IEC approval as needed, in collaboration with the country CTM/ CTMo.
• Ongoing support of Central/Local IRB/IEC process, such as submissions and approval tracking in CTMS. May support centralized IRB/IEC submission of safety events [ i.e., SUSARS, six-monthly line listings and Development Safety Update Report (DSUR)].
• Ongoing submission of documents to the eTMF and review/Quality Control (QC) of the eTMF to ensure accuracy and completeness including working with sites, CTM/CTMo., and study team to resolve issues related to missing or expired documents.
• Ongoing communication with sites and study teams regarding centralized study activities.
• Lead or ensure that that the global process for the ongoing collection and review of Financial Disclosure Forms is followed as specified.
• Maybe responsible for creation and management of standardized document templates.
• Assist with CSR distribution.
• Country and site level IC (Informed Consent) adaptati

Additional Information

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 .

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