Set and monitor the allocation of staff within a team of eTMF Specialists to ensure appropriate coverage of the BMS clinical book of work, allocating resources in accordance with project/trial priority status.
Accountable for the standard of uploading and quality review of electronic documents residing in the eTMF system to ensure inspection-readiness and compliance with the ICH GCP guidelines and ALCOA Plus principles.
Responsible for ensuring the team is appropriately trained to accurately apply required attributes, metadata, and workflows to uploaded documents in accordance with eTMF standards, to ensure effective document classification, management, identification, and retrieval.
Leads the hiring, performance management, and development of direct reports, ensuring timely objective setting and performance evaluations, and oversight of team training and compliance related to eTMF systems, procedural documents, and Health Authority regulations.
Collaborates cross‑functionally to support clinical trial processes, ensuring adherence to regulatory regulations and requirements for the maintenance of compliant TMFs and identifying opportunities for process efficiency.
Maintains a contemporary knowledge of regulatory requirements, guidance, and industry trends related to TMF compliance.
Communicates effectively, as appropriate, with relevant internal stakeholders to support TMF quality, timeliness, compliance, and issue resolution.
Leads and contributes to continuous improvement initiatives related to clinical trial documentation processes and TMF compliance.
Identifies and addresses TMF compliance gaps highlighted through Quality metrics, dashboards, and KPIs.
Undertakes remediation and/or targeted training activities, as required, to ensure eTMF documents meet defined quality standards and user/requestor requirements.
Supports the integrity of the departmental strategy and operating model by ensuring Quality Reviews are performed in accordance with company SOPs, Directives, and industry best practices, and that assigned Quality Reviews are accurately documented in designated systems of record
Requirements
Minimum 5-7 years of experience in health sciences or a related regulated industry.
Demonstrated supervisory skills and responsibilities for eTMF activities, including training, guidance, support, and coaching to team members.
Strong working knowledge of TMF principles, eTMF, and clinical document management systems, preferably Veeva Vault eTMF.
Strong organizational and technical skills, including the ability to create, interpret, and maintain reports and dashboards within eTMF systems.
Proficient in Microsoft Excel, PowerPoint, SharePoint and PowerBI for reporting, analysis, and documentation tracking.
Comprehensive knowledge of local and international regulatory requirements and guidelines relevant to TMF management and clinical trial documentation.
Demonstrated ability to develop and deliver TMF‑related training and coaching to a broad range of internal stakeholders and cross‑functional partners.
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Additional Information
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation. #HYDDD #LI-Hybrid
Position Summary:
This is a supervisory position overseeing a team of eTMF Specialists responsible for document upload and management in the electronic Trial Master File (eTMF) in support of BMS Clinical Trials across the enterprise.
Bristol-myers Squibb · Hyderabad - Ts, IN