Princeton LVL, NJ
6 days ago
Manager, Clinical Data Standards

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.

Manager, Clinical Data Standards, Bristol-Myers Squibb Company, Princeton, NJ. Manage activities associated with consistent implementation of global clinical data standards for projects and studies and assist in leading the development and maintenance of company’s global clinical data standards and related supportive processes. Develop and maintain global clinical data standards, including operational (Case Report Form (CRF) and non-CRF) Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), controlled terminology, non-CRF standard data mappings and other applicable industry standards. Participate in relevant study team meetings as standards subject matter expert and provide input for standards components, such as CRF design, CRF Completion Guidelines, Programmed edit checks, Data transfer specifications, SDTM mapping specifications and SDTM annotated CRF. Act as an expert on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards, and Clinical Data Interchange Standards Consortium (CDISC) controlled terminology. Consult study teams on validation of SDTM domains. Coach CROs and vendors on company’s data standards and related processes. Communicate and reinforce content and interpretation of company’s data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project. Process clinical data change requests for new or existing metadata, ensuring that the request is processed through the appropriate levels of the CDSGO. Participate in the committees of the CDSGO, partner with functional area stewards, organizing standards topics to be reviewed. Provide input and information to facilitate key discussions and decisions regarding standards use and implementation. Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide, XPT files). Develop CDSIC or cross functional SOPs, Working Procedures, Guidance documents, and job aids. Work on identification, review, evaluation, and implementation of new technologies related to data standards. Develop training materials and provide training on CDS-developed processes. Coach more junior personnel or contract staff. (R1592888)

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $161,470 - $194,270/yr.

MINIMUM REQUIREMENTS:

Master’s degree or foreign equivalent degree in Computer Information Systems, Computer Science, Health Science, or a related field, and five (5) years of post-baccalaureate related work experience.

In the alternative, the employer will accept a Bachelor’s degree or foreign equivalent degree in Computer Information Systems, Computer Science, Health Science, or a related field plus seven (7) years of post-baccalaureate related work experience.

Must have experience with/in:

CDISC Industry Standards (SDTM, ADaM, CDASH),Medidata Rave (EDC) and Metadata Repository (MDR), andSAS programming.

The required skills do not need to be maintained over the full term of required experience.

Any suitable combination of education, training or experience is acceptable.

To apply, email resume and reference R1592888 to resume.com@bms.com.

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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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.

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/

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