Clinical Trial Support Specialist Hiring Hyd | Bristol Myers Squibb

Bristol Myers Squibb as a Clinical Trial Support Specialist in Hyderabad

Bristol Myers Squibb (BMS) is a global leader in biopharmaceutical innovations, committed to transforming patients’ lives through science. This opportunity for a Clinical Trial Support Specialist in Hyderabad is perfect for professionals with a strong background in clinical documentation management, regulatory compliance, and project coordination.

Key Details of the Role

Job Title: Clinical Trial Support Specialist

Location: Hyderabad, Telangana, India

Type: Full-Time

Job ID: R1587313

What You’ll Do

As a Clinical Trial Support Specialist, you’ll play a pivotal role in ensuring the success of clinical trials. Your responsibilities include:

• In conjunction with the Submission Manager and the usee 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 submission documents.
• Ensures documents  are formatted  appropriately and Submission Ready Compliant (SRC)
• Collaborating with outsourced partners creates numbers for new and ongoing clinical trials.
• Enter site milestones and regulatory approval dates to maintain the quality and health of the trail assigned to it.
• Ensures Drug shipment addresses are entered correctly and feed 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 the 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 creating documents and document management systems and requirements (e.g. Core Template).
• Demonstrate understanding of the pharmaceutical industry and 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.

Qualifications Required

• Education: Bachelor’s or Master’s degree in Life Sciences or a related field.
• Experience: 2-4 years in clinical documentation management or a related field.
• Technical Proficiency: Familiarity with Veeva Vault, SAP, SharePoint, and CTMS systems.
• Skills: Strong organizational, time-management, and problem-solving abilities.

How to Apply

Take the next step in your career by joining Bristol Myers Squibb. Apply now for the Clinical Trial Support Specialist role in Hyderabad by visiting the official job listing:
Apply Here

Tagged as: Good Clinical Practice (GCP)