Pulmovant

Medical Director

• Serve as the Lead Clinical Programmer on Pulmovant sponsored clinical trials, utilizing Veeva CDMS, Medidata RaveEDC, and/or InForm as the primary electronic data capture (EDC) solutions.
• Perform hands-on design and build of Case Report Forms (CRFs), associated visit matrices, edit checks, rules and custom functions, or alternatively, oversee a Contract Research Organization (CRO) that performs these activities.
• Select and maintain clinical data tools, including performing product validation for the organization.
• Integrate multiple other critical clinical data products into EDC (e.g., Interactive Response Technology, electronic Patient Reported Outcomes, etc.) via API or other methods.
• Lead User Acceptance Testing (UAT) process for a cross-functional team, including authoring UAT plans and other required validation documentation.
• Participate in protocol review and study design discussion as subject matter expert on CDISC/CDASH best practices.
• Work closely with the Head of Clinical Data Management and other Biometrics leaders to build and maintain a growing global library of SDTM/CDASH compliant CRFs, edit checks, and downstream reports, listings, and visualizations.
• Perform and validate data migrations and/or post-production database changes needed after initial database go-live.
• Program project-specific metrics reporting, working across the project team to ensure reports meet the needs of all internal and external stakeholders.
• Author and maintain appropriate Standard Operating Procedures (SOPs) that govern the database build, handling, transfer, and cleaning processes.
• Oversee clinical database build timelines, in concert with the Lead Clinical Data Manager, Project Manager, and other critical study team members.
• Author and maintain Data Transfer Agreements with external vendors, in addition to being point of contact for any incoming or outgoing clinical data transfers via a secure method.
• Heavily support data management activities, including data review and cleaning, query resolution, data reconciliation, authoring Data Management documentation, and coordination of database freeze/lock deliverable.
• Train internal and external stakeholders on clinical database functionality as needed.
• Perform and own the user management process at a study-level.
• Primary point of contact for organization as business owner of multiple vendors, including notably the clinical database vendors.
• Oversee and drive vendor governance in this capacity.
• Own clinical data aggregation process and select appropriate technology tools to enable this (e.g., Veeva CDB).

Director, Clinical Database Programming