Document Coordinator, Global Trial Acceleration
3 weeks ago
**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 rich in diversity. Take your career farther than you thought possible.
BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Position Summary:
This individual contributor role has task-level responsibility for document and CTA (Clinical Trial Application) package creation which support all BMS Clinical Trials across the enterprise and engages closely with clinical trial vendors across multiple service categories of clinical trial activities in R&D.
Key Responsibilities:
- The Document Coordinator is responsible for managing and executing on centralized activities in support of global trials with an emphasis on clinical documentation.
- The Document Coordinator will interact with clinical study sites, Central/Local IRB/IECs, 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 clinical investigator sites.
- 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:
- Generation, processing, tracking and distribution of Confidential Disclosure Agreements (CDAs).
- Provide input into the creation of the feasibility questionnaire; distribution and tracking of the questionnaires; provide coordinated feedback to Global Trial Manager (GTM)/Global Trial Specialist (GTS), Clinical Trial Manager (CTM), Study Team and Business Insights & Analytics (BI&A) as applicable.
- 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)
- Responsible for Site Activation for clinical trials as applicable per region; this includes the final review of applicable documents, final sign-off of the site activation checklist, and submission to Regulatory. 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)
- 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.
- 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 relat
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