Senior Manager, Clinical Data Standards (R1554398-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
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
Lead and 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 and project 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 SME 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 project 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
Lead, facilitate and 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
Lead and participate in the development of CDSI or cross functional SOPs, Working Procedures, Guidance documents, and job aids.
Lead and 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.
Provide mentoring, coaching and escalation support to more junior personnel or contract staff, as required
Lead and participate in strategic initiatives, special projects, and working groups contributing to business decisions and process changes
Independently 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
At least 10 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 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
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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