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.
KeyDuties 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.
