Senior 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. Employer: Bristol-Myers Squibb Company Job Title: Senior Manager, Clinical Data Standards Location: 3551 Lawrenceville Road, Lawrence Township, NJ 08540 Wage Range: $163,032.00 - $194,270.00 Bristol-Myers Squibb Company is hiring a(n) Senior Manager, Clinical Data Standards (in Lawrence Township, NJ). Duties: Lead the development and maintenance of global clinical data standards, ensuring alignment with industry frameworks such as the Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), and controlled terminology. Oversee the creation of metadata, mappings between operational and SDTM standards, and documentation of standard usage. Serve as a subject matter expert in study and project team meetings, providing input on Case Report Form (CRF) design, CRF Completion Guidelines, programmed edit checks, data transfer specifications, SDTM mapping specifications, and annotated CRFs. Act as a consulting resource for project teams on operational data standards, SDTM, Analysis Data Model (ADaM), and CDISC controlled terminology. Support the validation of SDTM domains, leveraging industry-standard tools and custom validation programs to ensure data integrity and compliance. Telecommuting permitted a hybrid schedule as determined by the employer. Requirements: Employer will accept a Bachelor’s degree or foreign equivalent degree in Bioinformatics, Microbiology, or a related field and seven (7) years of post-bachelor, progressive, work experience as a Clinical Data Manager or related occupation. Must have seven (7) years of experience with/in: • The pharmaceutical development process; • Creating data mapping specifications utilizing industry standards, including Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Models (SDTM), or Analysis Data Models (ADaM); • Medidata Rave and Metadata Repository; • Interpreting and complying with Health Authority regulations; • Submission requirements, including annotated Case Report Forms, XPT files, and define.xml. Additionally, employees are eligible for an annual discretionary bonus, and benefits including Additionally, employees are eligible for an annual discretionary bonus, and benefits including healthcare, leave benefits, and retirement benefits. BMS operates a pay-for-performance compensation philosophy and your total compensation may vary based on role, location, and firm, department and individual performance. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: * Health Coverage: Medical, pharmacy, dental, and vision care. * Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). * Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability...