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Lawrence Township, New Jersey, United States
Hybrid
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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:
Work-life benefits include:
Paid Time Off
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.
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.
Supporting People with Disabilities
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.
Candidate Rights
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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R1603227 : Senior Manager, Clinical Data Standards