CDISC’s Post

Call for USDM Trainers! The TransCelerate BioPharma Digital Data Flow (DDF) initiative along with CDISC’s development of the Unified Study Definitions Model (USDM) aims to modernize clinical trials by transitioning from a document-centric to a data-centric approach, enabling automated study asset creation and system configuration. As the use and adoption of USDM increases, CDISC would like to identify qualified trainers to educate our community on key components such as the digital protocol, schedule of activities, Unified Study Definitions Model (USDM), and API specifications. Description: Trainers will support development of and deliver the CDISC standard USDM training through our standard Education delivery process focused on the implementation of USDM, ensuring stakeholders can effectively implement and utilize the standards to enhance clinical trial processes. Key Responsibilities: • Curriculum Development - Support ongoing updates to the training materials covering topics such as digital protocol, schedule of activities, USDM, and API specifications.  • Training Delivery - Conduct on-site or virtual training sessions for diverse audiences, including sponsors, CROs, and academic institutions.  • Feedback Integration - Collect and analyze participant feedback to continuously improve training effectiveness. Qualifications • Experience - Minimum of 5 years in clinical research, with a focus on clinical trial design, data management, clinical or statistical programming, or related areas.  • Technical Proficiency - Strong understanding of CDISC standards, preferably including USDM and ICH M11. Experience reviewing and understanding data models is strongly preferred.  • Training Expertise - Current or willing to become a CDISC Authorized Instructor.  Communication Skills: Excellent verbal and written communication abilities, with a talent for simplifying complex concepts. Application Process:  If you are interested, please apply using the Authorized Instructor Application by March 14th, as we will be coordinating a train-the-trainer session soon thereafter. Be sure to select ‘USDM’ as the course for which you are applying to teach. We will review all applications and get back to you as soon as possible. Authorized Instructor Application: https://lnkd.in/gUCaFaS2