Document Coordinator, Global Trial Acceleration

**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.

**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 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 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 generation of CSR appendices and CSR distribution as needed.
- 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.

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully