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 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.
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.
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Clinical Trial Support Specialist Hiring Hyd | Bristol Myers Squibb[/caption]
