Clinical Trial Support Specialist

Bristol Myers Squibb

2 - 4 years

5 - 9 Lacs

Hyderabad

Posted:1 day ago| Platform:

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Skills Required

sop gcp documentation bms ctms regulatory guidelines ich

Work Mode

Work from Office

Job Type

Full Time

Job Description

In conjunction with the Submission Manager, and use of technologies, simplify the end-to-end process for Clinical Trial documents, maintenance and submissions
Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs
Partners with the Submission Manager for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents
Ensures documents are formatted appropriately and Submission Ready Compliant (SRC)
In collaboration with out outsourced partners, creates site numbers for new and ongoing clinical trials
Enters site milestones and regulatory approvals dates to maintain the quality health of the trail assigned to
Ensures Drug shipment address are entered correctly, and feed to SAP to enable IP Supply to sites
Performs a reconciliation of Veeva (eTMF/CTMS) to ensure accurate data is available and reflecting correctly
Proactively analyzes and drives efficient problem solving within team's control
Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items
Demonstrates thorough knowledge of relevant BMS SOPs and policies and the ability to provide timely guidance in their application to Protocol and/or Program teams
Assesses operational feasibility using GCPs, ICH and regulatory legislation and guidelines as they apply to submission deliverables where applicable
Demonstrates strong project management skills
Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e g Core Template)
Demonstrate understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process
Manages interactions with senior level multifunctional teams across the oncology portfolio, to drive the operations submission documents
Other duties as assigned to support Clinical Trials
Performs other tasks as assigned

Experience Requirements

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