Line Head, TMF Central Upload and Quality Review

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.

Responsibilities:

• 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

Qualifications:

• 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.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1601595 : Line Head, TMF Central Upload and Quality Review