Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t 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\xe2\x80\x99ll 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: .

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.

Functional Area Description

The centralized TMF organization is responsible for the completeness and accuracy of the Trial Master File for all BMS-sponsored studies. The group will deliver technical expertise in the Trial Master File (paper TMF & electronic TMF) management and will provide support for the book of work for all BMS-sponsored clinical trials throughout the lifecycle of the trial. The group will support inspection readiness goals in compliance with ICH/GCP Guidelines, regulatory requirements and BMS internal policies.

Position Summary / Objective

Key deliverables include monitoring and assessing the overall health of the TMF, ensuring quality, completeness and timeliness in the eTMF for all and BMS-sponsored studies, working with the study teams and Clinical Trial Managers. Subject Matter Expert for TMF/eTMF, spans across all therapeutic areas and research phases, collaborates with cross-functional teams, TMF Contributors, TMF Content Owner, eTMF Business Operations and CRO/third party vendor during the close-out and archival cycle of the trials.

Position Responsibilities

• Monitor the adherence to ICH/GCP Guidelines, regulatory requirements and BMS policies as it relates to the completeness and accuracy of the TMF at the study level by ensuring the required documents reside in the TMF as per the Study-Specific Master Plan and Master List and are inspection ready at all times.
• At study completion, ensure the TMF is ready to be archived.
• Coordinate the long-term storage archival of original documents and maintain document integrity per retention policies.
• Ensure all expected documents are complete and final in eTMF in collaboration with TMF Content Owner and study team (study team serve as SME for their respective departments/functions).
• Work proactively and prospectively with TMF Content Owner and TMF Contributors at Study, Country and Site level to ensure timely reconciliation and archiving of all Essential Documents in the TMF.
• Ensure controlled access to eTMF Archive and other TMF-related archive systems, as applicable.
• Ensure systems owners take any necessary actions aimed to protect from unauthorized changes, as relevant to the specific TMF system.
• Ensure the study documentation received by third party is complete, includes a documentation inventory list, and meet quality criteria before archiving documents.
• For documents transferred from the CRO, ensure transfer to appropriate long-term archive location.
• For any documents that have been maintained in hard copy, prepare and pack the documents for archival at the designated BMS archiving vendor facility.
• Upon approval by TMF Archivist, transfer paper documents to archiving vendor per BMS procedures.
• Upon approval by TMF Archivist retrieve and return hard copy documents to the off-site archive vendor per BMS procedures.
• Periodically perform risk-based quality reviews of the TMF content by utilizing metrics and reports to assess any missing documents and then following-up with the appropriate functional group or document owner to mitigate, as per established review schedule.
• Monitor and identify TMF trends and escalate concerns to management.
• Generate, organize, and deliver on TMF performance metrics at the site, study, country and compound levels.
• Manage complex export requests for Health Authorities and divestitures and independently solve technical issues
• Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams.
• Assist in overall change management and build collaborative relationships with cross-functional team and third-party vendors.
• Participate in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved following a regulatory inspection.
• Exhibit good project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines.
• Display good time management skills, the ability to produce deliverables efficiently, meet timelines, and prioritize workload to meet business goals.
• Provide support to TMF implementation, internal audits and regulatory inspections.
• Demonstrate ability to make decisions, deliver on commitments, share knowledge, acknowledge other\xe2\x80\x99s achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment.

Degree Requirements

Minimum of Bachelor\xe2\x80\x99s degree in a scientific or related discipline

Experience Requirements

At least 3-5 years of TMF experience required, preferably in Veeva Vault eTMF, including experience in study start-up, maintenance, closeout and archival, and performing quality and completeness reviews.

Relevant experience in clinical trials related roles (i.e. clinical operations and project management).

Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines is desirable.

Key Competency Requirements

• Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices and International Council for Harmonization guidelines (E6(R2))
• Subject Matter Expert knowledge of clinical trial documentation, TMF Reference Model, clinical trial activities, archival and retention polices and related terminology
• Must have knowledge of Core, Country and Site level essential documents
• Must have ability to navigate eTMF system and show advance proficiency with Window Office tools
• 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
• Very strong communication and interpersonal skills, verbal and written, is required

Travel Required

On occasion

#HYDDD #LI-Hybrid

If you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 . Visit 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.

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

Bristol-Myers Squibb