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Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb  und machen Sie einen Unterschied. 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 protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off • US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure:  The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.” Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit  https://careers.bms.com/life-at-bms/. For more information on benefits, please click the “Life at BMS” tab above. To apply, click the “Apply Now” button at the top of this page. Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor. Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected] . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1603227 : Senior Manager, Clinical Data Standards