[Hiring] Director Clinical Database Programming @Pulmovant

Role Description

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.

Qualifications

• Bachelor’s degree or foreign equivalent in Biotechnology, Bioinformatics, or a related field.
• 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.
• Ten (10) years of experience with implementing and integrating Oracle, Medidata, or DataLabs EDC products with other clinical data systems.
• Two (2) years of recent experience in clinical data programming within a pharmaceutical or biotech company.
• Experience in pulmonary, cardiology, hematology, oncology, CNS, inflammation or immunology therapeutic areas.
• Three (3) years of experience as the subject matter expert within the clinical data programming discipline in a start-up or small biotech or pharmaceutical company.
• Experience programming in SQL and/or C#.
• Working knowledge of Veeva CDMS, Oracle InForm, Medidata Rave, IBM Clinical Development (Zelta), and DataLabs.

Requirements

• Must possess the following certifications: Veeva CDMS Certified Study Builder; Medidata RAVE Certified Study Builder; and Oracle Health Sciences InForm Recognized Study Builder (InForm / Central Designer).

Benefits

• Salary: $230,000 to $260,000 per year.
• 40 hours per week, Monday-Friday, 9:00 AM-5:00 PM.
• Incentives offered through the employee referral award program are applicable to this position.

Company Description

Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.