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 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 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. Degree Requirements 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. 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
