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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 rich in diversity. 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 .

eTMF Specialist- Job Description

Date Modified:05 November 2024

Job Title: eTMF Specialist

Division: Research & Development

• Functional Area Description: Global Development Operations / Trial Delivery Support / TMF & Transparency

Position Summary /Objective

• This individual contributor role has the main responsibility for document upload and management in the electronic Trial Master File (eTMF) in support of BMS Clinical Trials across the enterprise.

Position Responsibilities

• Responsible for managing and executing centralized activities supporting global trials with emphasis on clinical documentation.

• Upload and perform rigorous quality reviews of electronic documents residing in the eTMF system to ensure they are inspection-ready and are compliant with the ALCOA Plus principles.

• Apply filing attributes/metadata as appropriate/required to documents to facilitate classification, management, identification, and accessibility to retrieve files.

• Provide immediate feedback for any quality Issue findings.

• Interact with regional roles, the study team and other functional areas within BMS to manage document quality, timeliness and completeness and provide support to the study team throughout the study duration (start-up, maintenance, and close-out of clinical studies).

• Develops and maintains collaborative working relationships with clinical study teams.

• Review of essential regulatory documentation, including submission of final documents to the eTMF.

• May provide a level of quality control of start-up activities.

• Act as a single point of contact for the study team for centralized activities related to document management.

• Ongoing maintenance and tracking of essential records and collection of updated/outstanding documentation

• Proactively resolve issues related to missing or expired documents.

• Ongoing communication with study teams regarding centralized document management activities.

• Other duties are assigned to support Clinical Trials.

Degree Requirements

• Minimum of a bachelor's degree in Life science, Business Administration, or equivalent experience. Advance degree a plus.

Experience Requirements

• 1-2 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field.

• Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma.

• Experience in the use of industry Clinical Trial Master File Systems or equivalent. Experience with Veeva Vault Clinical preferred

• Experience with MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies.

• Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate.

Key Competency Requirements

• Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals.

• Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.

• Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.

• Ability to sustain high levels of performance in a constantly changing environment.

• Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.

• Ability to prioritize work and assess risk to meet the needs of the organization.

• Demonstrated ability to work independently and seek out support when needed.

• Proactive, adaptable and able to modify personal and organizational work style to meet the needs of the business.

• Exceptional written and oral communication skills."

Travel Required : No

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment: N/A

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 an inclusive culture, promoting diversity 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 a diverse 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.

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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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/

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

Company: Bristol-Myers Squibb

Req Number: R1587037

Updated: 2024-11-13 03:12:22.179 UTC

Location: Hyderabad-IN

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.