Manager, Clinical Data Standards
Working with Us
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Position Summary / Objective
The Clinical Data Standards Manager is a role considered essential to the development and sustainability of the Global Clinical Data Standards, compliant submissions and success of the BMS R&D pipeline. This role reports to the Associate Director, CDS.
The job responsibilities include two roles
Project Standards Manager (PSM) will manage the activities associated with the consistent implementation of global clinical data standards for BMS projects and studies
Global Standards Manager (GSM) will assist in the leadership of the development and maintenance of BMS’s global clinical data standards and related supportive processes
Each individual can perform PSM, GSM or a combination of the two roles.
Development, maintenance and Implementation of BMS clinical data Standards
Participate in the development and maintenance of global clinical data standards, including operational (CRF and non-CRF) CDISC Study Data Tabulation Model (SDTM), controlled terminology, non-CRF standard data mappings (e.g., lab or ECG), and other applicable industry standards. This could include creation of the metadata and mappings between the standards (operational and SDTM), and documentation of the use of the standard.
Participate in relevant study team meetings as standards SME and provide input for standards components, such as CRF design, CRF Completion Guidelines, Programmed edit checks, Data transfer specifications, SDTM mapping specifications and SDTM annotated CRF.
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.
Act as a consulting resource for study teams regarding the validation of SDTM domains, which may include output from industry standard software tools and BMS custom validation programs.
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
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
Process clinical data change requests for new or existing 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
Participate in the committees of the CDSGO, partner with functional area stewards, 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.
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 CDS 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 training materials and provide training on CDS-developed processes.
May coach more junior personnel or contract staff, as required
Participate in strategic initiatives, special projects, and working groups contributing to business decisions and process changes
Identify and propose process improvements while maintaining a strategic focus. Share new industry standards, best practices with project and study teams, and within department as required.
Bachelor’s degree required
Experience Requirements At least 7 years of relevant industry experience with clinical trials, preferably with clinical data standards as a focus
Key Competency Requirements
Experience in Industry Standards (e.g. CDISC) in either the collection (CDASH), tabulation (SDTM) or analysis (ADaM) models.
Experience with Medidata Rave(EDC) and Metadata Repository (MDR) 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 an inclusive culture, promoting diversity 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.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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