Senior Clinical Database Programmer, Pulmovant

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape. 

Pulmovant recently announced positive results from its Phase 2 PHocus study evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. PHocus met both primary and secondary endpoints including the highest ever reported pulmonary vascular resistance (PVR) reduction in any randomized controlled PH trial. The robust results, in conjunction with mosliciguat’s once-daily, inhaled administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD.  These data represent a significant advancement in a devastating disease that affects ~200,000 patients with no or very limited treatment options. A Phase 3 trial is currently underway. More details can be found in the press release here.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.

For more information, please visit https://www.pulmovant.com.

About Roivant:

Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com.

Position: Senior Clinical Database Programmer

Summary: 

The Senior Clinical Database Programmer provides technical oversight of EDC build and maintenance in Veeva CDMS and supports vendor data transfers, in partnership with the Lead Clinical Data Manager. The role offers technical support where needed, assesses the impact of post production changes, and requires 6 to 8 years of clinical database programming experience in an FDA regulated environment, with strong Veeva CDMS expertise.

Key Duties and Responsibilities 

• Provide technical oversight of EDC build and maintenance in Veeva CDMS, including review of specifications, configuration, and deliverables.
• Work with the Lead Clinical Data Manager to finalize build requirements that support data collection, review, and monitoring against study goals and endpoints.
• Assess the impact of post-production changes (such as amendments, new forms, and edit check updates) on existing data, integrations, and downstream deliverables, and review migration and validation plans.
• Review Veeva CDMS and DQS release notes to assess the impact on active studies, and work closely with IT to plan, test, and communicate any required impacts.
• Provide hands-on technical support to vendors and study teams where needed, including troubleshooting and issue resolution.
• Support site and user administration for Pulmovant managed studies in Veeva CDMS, including site and user account setup, role assignment, and access changes, in accordance with Pulmovant SOPs.
• Support vendor data transfers for external data collected outside the EDC, such as central lab, ECG, eCOA, and IRT data, including transfer specifications, test transfers, load validation, and ongoing production transfers.
• Provide technical oversight of Veeva DQS system for data ingestion and data listings build out, testing, and post-production changes.
• Support data reconciliation of vendor and EDC data in Veeva DQS, in coordination with Data Management.
• Support UAT and validation, including review of UAT plan and results and confirmation of defect resolution before go live.
• Monitor and drive vendor build timelines in coordination with the Lead Clinical Data Manager, Project Manager, and study team members.
• Confirm that any integrations with the EDC, such as eCOA and IRT, are implemented and tested.
• Maintain documentation of process adherence in accordance with Pulmovant SOPs and confirm vendor documentation is inspection ready.
• Support metrics reporting, data listings, and database freeze and lock deliverables.
• Train internal and external stakeholders on clinical database functionality as needed.

Education and Experience

The position requires a Bachelor’s degree in Biology, Chemistry, Physics, Computer Science, Information Technology, Biotechnology, Bioinformatics, or a health related field (or foreign equivalent), followed by 6 to 8 years of progressively responsible clinical data programming experience in the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA regulated environment. Experience must include:

• At least 4 years of hands-on experience reviewing, building, and maintaining databases in Veeva CDMS, with strong working knowledge of study design, forms, edit checks, and custom functions.
• Experience in EDC builds and post-production changes, including impact assessment and change control.
• Experience with vendor data transfers, including authoring transfer specifications, ingesting test transfers, and load validation for external datasets.
• At least 6 years of experience in data management and/or database programming for different phases of clinical trials within the ICH GCP and regulatory environment.
• Working knowledge of data reconciliation, UAT, change control, and integration of study systems with the EDC, such as IRT.

Preferred Qualifications

• Veeva CDMS build certification.
• Experience with Veeva DQS for data review and reconciliation.
• Experience supporting site and user management in a sponsor hosted EDC environment.
• Experience mentoring or guiding junior programmers and CRO or vendor database teams.

 

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.

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