Director Clinical Database Programming (10031080)

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TITLE : Director Clinical Database Programming (10031080) EMPLOYER : Pulmovant Inc. LOCATION: Waltham, MA (Option to work remotely from any location in the U.S.) DUTIES: 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). May oversee a small team of data management personnel in a direct or indirect relationship. REQTS: Must have a Bachelor's degree or foreign equivalent in Biotechnology, Bioinformatics, or a related field plus fourteen (14) years of experience with Electronic Data Capture (EDC) systems and clinical data programming in an FDA-regulated environment within a pharmaceutical or biotech company in the position offered or a related position. Must possess ten (10) years of experience with all of the following: Implementing and integrating Oracle, Medidata, or DataLabs EDC products with other clinical data systems, including experience integrating EDC with each of the following: randomization and trial supply management (IRT/RTSM), Medical Coder, and Electronic Clinical Outcome Assessments (eCOA)/Electronic Patient Reported Outcomes (ePRO); Performing clinical data programming, including two (2) years of the most recent experience gained within a pharmaceutical or biotech company, overseeing CRO support and performing complete in-house project support (including database build and go-live, data cleaning and query management, external data reconciliations, and database lock); Performing clinical data programming for pulmonary, cardiology, hematology, oncology, CNS, inflammation or immunology therapeutic areas; Managing vendors and serving as primary point of contact for clinical trials; Performing data management/database development for different phases of clinical trials, including writing programs in SAS 9.4 or higher for delivery to other project stakeholders for use; Functioning as an organizational relationship manager for data management systems (specifically, EDC vendors), leading vendor governance and providing organizational performance feedback. Must possess three (3) years of experience with all of the following: Functioning as the subject matter expert within the clinical data programming discipline in a start-up or small (less than 100 employees) biotech or pharmaceutical company; Authoring Standard Operating Procedures (SOPs) that govern the clinical database programming processes for the organization; Performing traditional data management activities within a clinical study, including cleaning clin

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