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Global Trial Acceleration Associate

Global Trial Acceleration Associate

Bristol Myers Squibb

11 - 14 years

16 - 18 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

procurement pharmacy clinical trials site monitoring data privacy manager quality control document management outsourcing operations recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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Global Trial Acceleration Associate