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Clinical Database Programmer

Penfield Search Partners

Job Location:

Fairfield, OH - USA

Monthly Salary: Not provided by the employer

Posted: 19 September 2026 (4 days ago)

Application Deadline: 21 December 2026

Vacancies: 1 Vacancy

Job Summary

Job Description

Contact: Neisha Camacho/Terra Parsons -
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.

Required Experience:

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