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Position Summary / Objective
The Clinical Data Standards & Reporting Engineer is a role considered essential to the development and sustainability of the Global & TA Clinical Standards that ensure compliant submissions and success of the BMS R&D pipeline. This role reports to the Associate Director, Clinical Data Standards & Reporting
Position Responsibilities
The job responsibilities can include the following:
Study and Project Support
- Serve as the primary point of contact for study teams members on the usage and development of BMS standards including, but not limited to:
- Clinical Scientist for protocol standards
- DB developers for collection standards
- SDTM Programmers for SDTM standards
- Statistical programmers for ADaM and TLFs standards
- Guide study teams in interpreting and applying end to end standards for implementation into a clinical trial (e.g. protocol, data collection, SDTM, ADaM, TLFs, etc.) for both global and TA standards helping them to ensure compliance to regulatory needs and alignment to industry standards.
- Participate in relevant study team meetings as a Standards SME and provide interpretation and rationale for standards components as needed.
- Act as a consulting resource for study team members regarding the validation of the CDISC compliant submission packages and relevant submission documents.
- Communicate and reinforce content and interpretation of BMS standards to project and study teams, to ensure consistency in understanding and implementation across a project.
- Process clinical standard change requests for new or existing metadata, including developing a recommendation and implementation plan for the standards end-to-end as well as ensuring that the request is processed through the appropriate standards governance framework.
- Participate in Study / Submission team meetings, as applicable.
Global & TA Standards Development
- Contribute to the development of global and indication- or TA-specific standards, aligned with CDISC and internal BMS frameworks.
- Create and maintain global and TA libraries of standard metadata including but not limited to protocol, data collection, SDTM, and analysis standards.
- Create and maintain global and TA submission standards including but not limited to define.xml, aCRF, and Reviewer’s Guides.
- Support complex implementation scenarios, including developing guidelines and ensuring Regulatory/CDISC compliance.
- Support harmonization efforts across Clinical, Biometrics, Data Management, and Regulatory functions.
- Participate in the development and maintenance of global and TA clinical standards including but not limited to CRF and non-CRF CDASH data collection, CDISC Study Data Tabulation Model (SDTM) mapping, controlled terminology, and other applicable industry standards. This includes documentation of the use of the standard.
- Act as an expert on industry standards (e.g. SDTM, Analysis Data Model (ADaM), Clinical Data Interchange Standards Consortium (CDISC) controlled terminology).
Governance & Process Management
- Evaluate and process change requests for new or modified global and TA standards ensuring that the request is processed through the appropriate standards governance framework.
- Support the standards governance framework ensuring timely and compliant implementation of approved standards.
- Support documentation and rollout of standards via SOPs, job aids, and training.
- Review and implement technical change requests related to standards, mappings, and macros.
- Act as a liaison between the standards governance framework and project teams
- Support standards governance committees, partnering with functional areas, organizing standards topics to be reviewed, and ensuring decisions are made in a timely manner, documented in meeting minutes and other forms, and implemented. Provide input and information to facilitate key discussions and decisions regarding standards use and implementation.
- Develop training materials and provide training on clinical data standards and reporting developed processes.
- Participate in strategic initiatives, special projects, and working groups contributing to business decisions and process changes.
- Share new industry standards, best practices with project and study teams, and within department as required.
Tools & Systems
- Serve as technical SME for systems such as Medidata Rave, MDR, SDTM validation platforms (e.g., Pinnacle 21), and SAS & R coding systems.
- Coach CROs and vendors on technical implementation of BMS standards.
- Work with standards management systems and software, such as Metadata Repository, Change Request systems, SDTM validation systems, and issues tracking systems, in the development of systems and processes for creation and maintenance of BMS standards, including specifications, mappings between standards, and checking adherence to these clinical standards.
- Participate in the identification, review, evaluation, and implementation of new technologies related to clinical standards.
- Develop or maintain clinical data transformation tools, including standard macros and programs.
Degree Requirements
- Bachelor’s degree required
Experience Requirements
- 8 to 11 years of relevant industry experience with clinical trials, preferably with clinical data standards as a focus.
- Experience in Industry Standards (e.g. CDISC) in either protocol (USDM), the collection (CDASH), tabulation (SDTM) or analysis (ADaM) models.
- Experience with Medidata Rave (EDC) and/or Metadata Repository (MDR) and/or SDTM programming is preferred.
- Experience interpreting Health Authority regulations with a strong compliance background.
- Strong working knowledge of the overall pharmaceutical development process.
- Strong working knowledge of SDTM and the creation of data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml.
- Experience in CRF design, query resolution, and general data validation.
- Good communication skills, high ability to communicate standards related issues, options, and their impact to project teams and within department.
- Ability to work effectively in a team environment with medical personnel, study managers, project managers, clinical monitors, data managers, programmers, and statisticians
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. 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.
R1601174 : Senior Manager, Clinical Data Standards & Reporting Engineer
