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. Coach CROs and vendors on BMS standards and related processes. 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. Contribute to/Lead the development of global and indication- or TA-specific standards, aligned with CDISC and internal BMS frameworks. Support complex implementation scenarios, including developing guidelines and ensuring Regulatory/CDISC compliance. Support/Lead 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. Participate in industry working groups related to industry standards. 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. 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. Participate in the development of GBDS or cross functional SOPs, Working Procedures, Guidance documents, and job aids. Develop training materials and provide training on clinical data standards and reporting developed processes. Participate in/Lead strategic initiatives, special projects, and working groups contributing to business decisions and process changes. 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/Drive 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. Design and innovate clinical data transformation tools and systems. Supporting People with Disabilities Bachelor's degree required At least 12 to 15 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