Lead Cdm, Consultant
Current• Lead cross functional team meeting for DM tasks and establish expectations for dataset content and structure. Actively work with CRO for Study Set Up activities, grant access for various CRO roles, provide training as needed. Work with Clinical, Operations and Stats team to gather content and integration requirements for electronic Case Report Forms and other data collection tools. Set timelines and follow-up regularly to ensure delivery of all Data Management milestones. Query data for validation of clinical data, perform UAT and Database Lock activities.• Ensure real-time inspection readiness of all Integrated Data Services (IDS) deliverables for the trial. Participate in Regulatory Agency and Johnson & Johnson internal audits as necessary.• Perform trial level oversight controls as described in the oversight plan, QC process and work instructions. Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.• Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.• Supported vendor evaluation, selection, contracting, and oversight activities for Global Data Management.• Set up Clinical Study database in RAVE iMedidata Set up. Lead UAT process & compliance documentation.• Standardization of DMP, Data Std., eCRF specification, DVS, eCRF CG, UAT release & Migration doc.• Support the implementation of study metrics; timeline development, training, and mentoring coworkers.• Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and SDTM standards for medical devices for use in the MD sector; participate in industry initiatives to define SDTM standards.
