Director, Clinical Database Programming (10031080)

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 Rave EDC, 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.

Requirements

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 work.