eTMF Operation Analyst

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 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.

• Job Title: eTrial Master File Analyst
• Division: Global Development Operations/Global Clinical Compliance and Continuous Improvement/Global Clinical Documents, Submissions and Disclosure
• Functional Area Description:

eTMF Operations is responsible for the completeness and accuracy of the Trial Master File for all BMS-sponsored studies at the document level. Deliver technical expertise in the Trial Master File (TMF) and electronic TMF (eTMF). Provide support for the book of work for all BMS-sponsored clinical trials throughout the lifecycle of the trial and support inspection readiness goals in compliance with ICH/GCP guidelines. Perform various eTMF Business Administrator tasks associated with eTMF that includes, reports, metrics, controlled document templates, and other role-specific tasks. Support Quality Review/Quality Validation activities for active studies in eTMF. To deliver technical and document expertise in the Trial Master File (eTMF). Develop, execute and review User Acceptance Testing scripts for eTMF changes/enhancements while working in conjunction with eTMF IT. Provide support for all clinical trials throughout the lifecycle of the trial and what is in the book of work, support inspection readiness goals in compliance with ICH/GCP guidelines.

Position Summary / Objective       

• Key deliverables include Uploading and applying metadata to documents across all classifications, ensuring quality and completeness at the document level in the eTMF for all BMS-sponsored studies. Serves as Subject Matter Expert for eTMF and the TMF Reference Model that spans across all therapeutic areas and research phases, collaborates with cross-functional, global clinical research studies throughout the lifecycle of the trials. Perform all activities required as a Business Administrator role in eTMF.

Position Responsibilities    

• Recognizes, confirms quality, completes all required metadata when uploading documents into eTMF, maintaining high quality standards and completes process within required timelines
• Monitors the adherence to ICH/GCP Guidelines, regulatory requirements, ALCOA+ Principles and BMS policies as it relates to the completeness and accuracy of the TMF at the document level.
• Exhibits knowledge of critical and essential documents to be able to perform Quality Validation checks on documents that have had completed Quality Review.
• Performs the role of Subject Matter Expert by sharing the knowledge of clinical trial documentation, TMF Reference Model, navigation of the eTMF system, clinical trial activities and related terminology.
• Actively performs Business Administrator role in eTMF and all tasks associated with this role.

• Manages complex tasks within a Trial Master File, including Template and Report creation and maintenance.
• Participates in all activities associated with eTMF UAT: creating/writing/drafting UAT scripts, executing scripts, reviewing and/or approving scripts for all eTMF system releases
• Ability to make sound business decisions based on evidence (guidance documents and Manual of Operations) and experience regarding the outcome of the work that is performed that involves critical or complex documents.
• Participates in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved following a regulatory inspection
• Applies project management principles to any project that is assigned in order to best estimate the time allocation required to complete the project.
• Communicates to team members and management status of any eTMF work and shares status of projects
• Demonstrates ability to make decisions, deliver on commitments, share knowledge, acknowledge other achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment

Degree Requirements           

• Minimum of bachelor’s degree in a scientific or related discipline

Experience Requirements 

• At least 3-5 years of eTMF, preferrable using Veeva Vault eTMF, and clinical trial experience.  Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment. 

Key Competency Requirements   

• Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices and International Council for Harmonization guidelines (E6(R2))
• Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review.
• Experience managing clinical content in a records management system or electronic Trial Master File system.
• Have strong communication skills, verbal and written. 

• Travel Required     As needed
• Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment     

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/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.