Senior Manager, Clinical Data Standards

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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: $ - $

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…