We are currently looking for a professional to join our client in the Santa Ana, CA, area to lead software development and programming initiatives for their Clinical Data Management System. We are looking for someone who is passionate about healthcare and CDMS. This position offers an opportunity to work within a progressive company which utilizes the most up-to-date technologies, while putting an emphasis on a collaborative, family-oriented company culture. The Merge Developer role is either part of the Clinical Data Management Systems (CDMS) group involved in clinical database build and maintenance or the Clinical Data Services (CDS) group involved in clinical data receipt, programming, and delivery. This role is responsible for overseeing Clinical Data Management System set up and maintenance as well as providing advanced technical support related to Clinical Data Management Systems required for clinical studies.
Overview of the Role
The Merge Developer participates in activities related to building study databases and applies competent knowledge of the programming of moderate CRF design, database building, edit checks, reports, custom programming, system interfaces, and all system feature configurations.
Serves as the lead on study-specific database design within the CDMS system, leading clinical database programming activities on multiple studies of simple to moderately complex design and expert in all areas for relevant CDMS.
Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
Builds clinical study database CRF screens per CRF Specifications provided by the project team.
Creates/Programs edit checks, special actions/functions, custom programs, and derivations as per a DVS.
Plans and schedules edit check test script writing, edit check programming, and edit check validation with the centralized CDMS Testing group and centralized CDMS Programming group. Manages timelines for the edit check process, ensures issues are addressed in a timely manner to meet timelines, and produces edit check validation packages for delivery to the study teams to file in the Trial Master File.
Completes study database updates as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes.
Configures study-specific data interfaces such as IVRS, labs, and CTMS.
Serves on project teams to coordinate and lead CDMS activities for clinical database programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem-solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
Troubleshoots and solves study building issues and/or system integration issues (such as IVRS failures, CTMS issues), and/or change request issues using the appropriate applications.
Creates advanced CDMS custom programs as per DVS, as required.
Ensures high-quality deliverables by providing a review of study-level/program-level I multi-study core deliveries for accuracy.
Attends sponsor audits and assists with in-progress audits, including presenting the CDMS process and procedures and presenting the validation documentation produced by the CDMS group.
To participate and contribute towards internal user group meetings to share knowledge and providing the latest updates/features. Participate in Data Management department initiatives.
Plan for the study execution in detail thereby providing clarity on all aspects of the setup progress (Round 1 programming date, testing dates, UAT dates).
Role Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Minimum 2 years of experience in building study databases (CDMS) or a minimum of 4 years of experience in clinical data programming and delivery (CDS).
Prior experience in building study databases (CDMS) or clinical data programming and delivery (CDS).
Experience in IBM Merge, Oracle RDC, Phase Forward Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical, or CRF WorkManager required (CDMS only).
Demonstrated ability to produce CDISC and Sponsor defined clinical data deliverables (CDS only).
Experience with clinical data programming and the ability to review and evaluate clinical data (CDS only).
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