Contact: Neisha Camacho/Terra Parsons -
teamnt@penfieldsearch.com
No 3rd party candidates
The Clinical Database Programmer is responsible for the hands-on design, build, testing, deployment, and ongoing maintenance of clinical trial databases within Medidata Rave. This individual will support studies throughout the full database lifecycle, from protocol review and initial database development through production maintenance, database amendments, data cleaning, and database lock.
The ideal candidate will have extensive hands-on Medidata Rave programming experience and the ability to independently build and maintain clinical databases while also supporting traditional clinical data management activities. This role requires a strong technical understanding of clinical data collection, database design, edit checks, data quality, external data integrations, and downstream data requirements.
Responsibilities
- Design, build, program, test, deploy, and maintain clinical trial databases in Medidata Rave in accordance with study requirements, company standards, and industry best practices.
- Translate study protocols and data collection requirements into effective eCRF and clinical database designs.
- Schedule and lead eCRF design and review meetings with Data Management and cross-functional study team members.
- Develop and maintain eCRFs, edit checks, validations, derivations, forms, fields, folders, dictionaries, and other database components within Medidata Rave.
- Perform ongoing post-production database maintenance, including database amendments, configuration changes, edit check updates, troubleshooting, and other modifications required throughout the study lifecycle.
- Assess the impact of database changes and perform appropriate programming, testing, documentation, deployment, and post-production verification.
- Develop, review, execute, and document database testing and User Acceptance Testing (UAT) to ensure database functionality and data quality prior to production release and following database amendments.
- Review and maintain validation/edit checks for both internally managed and outsourced studies.
- Perform traditional clinical data management activities as needed, including data review, query generation and resolution, discrepancy management, data cleaning, reconciliation, and preparation for database freeze and lock.
- Monitor production databases and identify and resolve database, data entry, edit check, and data quality issues.
- Provide technical expertise, troubleshooting, and ongoing database support to the Clinical Data Management team.
- Routinely interface with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, and other cross-functional team members.
- Act as a liaison with CROs and external vendors and support the development and maintenance of external data transfer specifications.
- Retrieve, load, review, and reconcile data received from CROs, central laboratories, and other external vendors.
- Develop, program, test, and maintain data review listings and tools using JReview, SAS, and/or other applicable technologies to support ongoing data review and cleaning activities.
- Perform post-processing of clinical data extracts in accordance with applicable standards for delivery to Biostatistics and Statistical Programming.
- Ensure database design and data collection standards support CDISC/CDASH requirements and downstream SDTM programming.
- Support user access, roles, permissions, and other study-level database configuration as needed.
- Make clinical data available to appropriate company personnel and regulatory agencies when required.
- Manage multiple study priorities and timelines while ensuring database programming and maintenance deliverables are completed accurately and on schedule.
- Develop and maintain appropriate database and Data Management documentation throughout the study lifecycle.
- Follow applicable SOPs, FDA/ICH guidelines, GCP, GCDMP, and industry standards.
Requirements
- Masters degree in Computer Science, Life Sciences, Health Sciences, Mathematics, Statistics, or a related scientific or technical discipline.
- Minimum of 5 years of clinical database programming and/or clinical data management experience within the pharmaceutical, biotechnology, or clinical research industry.
- Advanced hands-on Medidata Rave database programming and build experience is required.
- Demonstrated ability to independently design, build, program, test, deploy, and maintain clinical databases in Medidata Rave.
- Strong experience with eCRF design, database configuration, edit check programming, validation, testing/UAT, database amendments, and production database maintenance.
- Experience supporting databases throughout the complete study lifecycle, including post-build maintenance through database freeze and lock.
- Hands-on knowledge of traditional clinical data management activities, including data cleaning, query management, discrepancy resolution, reconciliation, and database lock activities.
- Detailed knowledge of clinical database design, case report form design, data validation, central laboratory data, and external/vendor data.
- Strong understanding of clinical trial design and the relationship between Clinical Data Management, Biostatistics, Statistical Programming, and Clinical Operations.
- Knowledge of FDA/ICH guidelines, GCP, GCDMP, and applicable industry standards.
- Knowledge of SQL and experience working with clinical data extracts and data transfer processes.
- Ability to work effectively with Data Managers, clinical personnel, medical staff, statisticians, statistical programmers, and other cross-functional partners.
- Strong analytical, troubleshooting, organizational, and problem-solving skills.
- Excellent verbal and written communication skills.
- Ability to independently manage competing priorities and study timelines while maintaining a high level of accuracy and attention to detail.