At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely engaging and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

• 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 legislati

📌 Clinical Trial Support Specialist (Hyderabad)
🏢 Bristol-Myers Squibb
📍 Hyderabad