Senior Clinical Database Programmer

🔥 12 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

👻 Ghost score 23%

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Pulmovant

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.

📋 Description

• 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 supporting data collection, review, and monitoring against study goals and endpoints • Assess the impact of post-production changes on existing data, integrations, and downstream deliverables; review migration and validation plans • Review Veeva CDMS and DQS release notes and coordinate with IT on required impacts • Provide technical support to vendors and study teams, including troubleshooting and issue resolution • Support site and user administration in Veeva CDMS • Support vendor data transfers for central lab, ECG, eCOA, and IRT data • Provide technical oversight of Veeva DQS for data ingestion and listings build out, testing, and post-production changes • Support data reconciliation of vendor and EDC data • Support UAT and validation, including review of plans and results and defect resolution before go-live • Monitor and drive vendor build timelines with the Lead Clinical Data Manager, Project Manager, and study team • Confirm EDC integrations such as eCOA and IRT are implemented and tested • Maintain SOP and inspection-ready vendor documentation • Support metrics reporting, data listings, database freeze, and lock deliverables • Train internal and external stakeholders on clinical database functionality

🎯 Requirements

• Bachelor’s degree in Biology, Chemistry, Physics, Computer Science, Information Technology, Biotechnology, Bioinformatics, or a health related field (or foreign equivalent) • 6 to 8 years of progressively responsible clinical data programming experience in the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA regulated environment • At least 4 years of hands-on experience reviewing, building, and maintaining databases in Veeva CDMS • 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 • Veeva CDMS build certification preferred • Experience with Veeva DQS for data review and reconciliation preferred • Experience supporting site and user management in a sponsor hosted EDC environment preferred • Experience mentoring or guiding junior programmers and CRO or vendor database teams preferred

🏖️ Benefits

• Equal employment opportunities and protection against discrimination and harassment • Role as part of the Roivant family of companies, leveraging collaboration and innovation

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