Director, Clinical Database Programming

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as the Lead Clinical Programmer for Pulmovant-sponsored clinical trials, employing Veeva CDMS, Medidata RaveEDC, and/or InForm as the primary electronic data capture (EDC) solutions.

• Engage in the hands-on design and construction of Case Report Forms (CRFs), along with associated visit matrices, edit checks, rules, and custom functions, or alternatively supervise a Contract Research Organization (CRO) responsible for these tasks.

• Choose and manage clinical data tools, which includes conducting product validation for the organization.

• Integrate various other essential clinical data products into EDC (e.g., Interactive Response Technology, electronic Patient Reported Outcomes, etc.) using API or other methods.

• Lead the User Acceptance Testing (UAT) process for a cross-functional team, including the preparation of UAT plans and other necessary validation documentation.

• Participate in protocol review and study design discussions as a subject matter expert on CDISC/CDASH best practices.

• Collaborate closely with the Head of Clinical Data Management and other leaders in Biometrics to establish and maintain a growing global library of SDTM/CDASH compliant CRFs, edit checks, and downstream reports, listings, and visualizations.

• Conduct and validate data migrations and/or post-production database modifications necessary after the initial database go-live.

• Program project-specific metrics reporting, collaborating with the project team to ensure reports satisfy the needs of all internal and external stakeholders.

• Create and update appropriate Standard Operating Procedures (SOPs) that govern database build, handling, transfer, and cleaning processes.

• Oversee clinical database build timelines in conjunction with the Lead Clinical Data Manager, Project Manager, and other key study team members.

• Draft and maintain Data Transfer Agreements with external vendors, serving as the point of contact for any incoming or outgoing clinical data transfers via secure methods.

• Provide significant support for data management activities, including data review and cleaning, query resolution, data reconciliation, authoring Data Management documentation, and coordinating database freeze/lock deliverables.

• Educate internal and external stakeholders on clinical database functionality as necessary.

• Manage user processes at the study level.

• Serve as the primary point of contact for the organization as the business owner of multiple vendors, particularly clinical database vendors.

• Oversee and lead vendor governance in this role.

• Control the clinical data aggregation process and select suitable technology tools to facilitate this (e.g., Veeva CDB).

⛳️ Requirements

• A Bachelor’s degree or equivalent in Biotechnology, Bioinformatics, or a related field, along with 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.

• Ten (10) years of experience in 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);

• Experience in clinical data programming, including at least two (2) years of recent experience gained in 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);

• Clinical data programming experience in pulmonary, cardiology, hematology, oncology, CNS, inflammation, or immunology therapeutic areas;

• Vendor management experience and acting as the primary point of contact for clinical trials;

• Data management/database development experience across various phases of clinical trials, including writing programs in SAS 9.4 or higher for delivery to other project stakeholders;

• Functioning as an organizational relationship manager for data management systems (specifically, EDC vendors), leading vendor governance and offering organizational performance feedback.

• Three (3) years of experience functioning as the subject matter expert within the clinical data programming discipline in a start-up or small (fewer than 100 employees) biotech or pharmaceutical company;

• Experience in authoring Standard Operating Procedures (SOPs) governing the clinical database programming processes for the organization;

• Experience in performing traditional data management activities within a clinical study, such as cleaning clinical data, issuing and responding to queries, and interfacing with clinical site personnel for support;

• Proficiency in programming in SQL and/or C# to create custom reports or functions within EDC or another clinical reporting tool;

• Familiarity with Veeva CDMS, Oracle InForm, Medidata Rave, IBM Clinical Development (Zelta), and DataLabs.

• Required certifications include: Veeva CDMS Certified Study Builder; Medidata RAVE Certified Study Builder; and Oracle Health Sciences InForm Recognized Study Builder (InForm / Central Designer).

🏝️ Benefits

• Incentives are available through the employee referral award program for this position.

• Pulmovant is committed to providing equal employment opportunities to all employees and applicants for employment, prohibiting discrimination and harassment of any kind based on 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.