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Development, maintenance and Implementation of BMS clinical data Standards
- Participate in the development and maintenance of global clinical data standards, including operational (eCRF and external) CDISC Study Data Tabulation Model (SDTM), controlled terminology, external standard data mappings (e.g., lab or ECG), and other applicable standards. This could include creation of the metadata and mappings between the standards (operational and SDTM), and documentation of the use of the standard.
- PSM will develop and maintain global data standards, considering the needs of individual studies within the indication, while following BMS standards conventions. Make decisions in conjunction with GSM regarding when project data standards can and should deviate from BMS global data standards. Data standards will include, but not be limited to, the CDISC Study Data Tabulation Model (SDTM), Controlled Terminology, or other relevant, current industry standards models.
- Participate in relevant study team meetings and provide standards expertise for the following standards components, including:
- CRF design, ensuring consistent CRF standards (including metadata) are used for all studies in a project
- CRF Completion Guidelines, to ensure consistency across studies within a project in how and when CRFs are completed
- Programmed edit checks, to ensure consistency across the studies within a project
- Data transfer specifications, to ensure consistency across the project in external data structure to facilitate mapping to the SDTM standard
- SDTM mapping specifications and SDTM annotated CRF, to ensure consistent SDTM mapping for studies within a project
- Act as an expert on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards, and Clinical Data Interchange Standards Consortium (CDISC) controlled terminology.
- 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 data standards, including specifications, mappings between standards, and checking adherence to these data standards.
- Coach CROs and vendors on BMS data standards and related processes
- Act as a consulting resource for study teams regarding the validation of SDTM domains, which may include output from software tools such as OpenCDISC and BMS custom validation programs.
- Communicate and reinforce content and interpretation of BMS data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project.
Standards Governance Organization and submissions support
- Participate in the committees of the CDSGO, 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.
- Participate various components of BMS’s CDSGO, including special-purpose working groups or committees.
- Process clinical data change requests for new metadata, including developing a Standards manager recommendation and implementation plan for the standard, as applicable, and ensuring that the request is processed through the appropriate levels of the CDSGO
- Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide, XPT files).
- Participate in Study / Submission team meetings, as applicable.
Other Key Activities
- Participate in the development of CDSI or cross functional SOPs, Working Procedures, Guidance documents, and job aids.
- Participate in the identification, review, evaluation, and implementation of new technologies related to data standards.
- Develop materials and provide training on CDSI-developed processes.
- Ensure effective communication and collaboration between the CDSI group and other functional groups impacted by clinical data standards.
- May coach more junior personnel or contract staff, as required
- Participate in strategic initiatives, special projects, and working
- Independently develop and propose innovative solutions, and share best practices with project and study teams, and within department as required.
- Identify root cause of problems and implement creative solutions
- Independently identify and propose process improvements while maintaining a strategic focus.
- BA/BS in a relevant health science or computer science discipline; minimum experience: 10 years as a clinical programmer, data manager, or data standards manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience. Medical background is a plus.
- 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.
- Project management and negotiation skills.
- Ability to work effectively on an independent basis in a cross-functional team environment, across BMS departments, and with external vendors
- Computer skills: knowledge of data structures within clinical data management systems, especially electronic data capture systems; understanding of SAS, including ability to use SAS System Viewer and to create basic SAS queries. Experience in programming databases is a plus. Experience with a Metadata Repository or other related standards management system is preferred.
- 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
- Experience with regulatory submissions or working with submission teams
Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data
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 the resources to pursue their goals, both at work and in their personal lives.