Clinical Programmer

A Clinical Programmer will support the design, development, and validation of clinical trial databases.

In this role, you will build and test study databases using platforms such as Medidata Rave or OmniComm TrialMaster, program validation checks, and ensure all data structures align with approved CRFs and study specifications.

You will perform comprehensive user acceptance testing, support data cleaning through query management, and maintain complete documentation in accordance with SOPs.

This position requires strong analytical skills, accuracy, and the ability to collaborate effectively with Clinical Data Managers and cross‑functional study teams to deliver high‑quality, audit‑ready clinical data on time and within budget

What You'll Do:


* Act as a primary database architect for client clinical databases using Medidata Rave, OmniComm TrialMaster, or other database applications as needed for Clinical Trials
+ Create database entry screens based on approved case report form (CRF) casebook
+ Perform internal testing of entry screens prior to user acceptance testing
+ Work with lead CP or Study Clinical Data Manager to implement system edits on built entry screens


* Program validation procedures, in conjunction with the Sr.

CP or CP II, for clinical studies and other billable projects.

Validation procedures are programming code that output edit failures in CTI systems when checking the data against expected values.

These expected values could be acceptable ranges or form flow edits/visit progression.


* Maintain necessary study build documentation as required by CTI SOPs


* Meet all project deadlines on time and on budget


* Ensure accuracy of clinical databases as compared to the CRF; perform user acceptance testing (UAT) of database and provide feedback to study team regarding any discrepancies


* Perform UAT on programmed edits in the clinical database; ensure accuracy of edits in database as compared to edit specifications documents; provide feedback to study team on functioning of edits.

The UAT the CP I performs is comprehensive and in conjunction with the Sr.

CP or CP II direction.

The programmers are to test the forms they have built as well as any edits or derivations that they have programmed.


* Perform review and issue queries for CRF data, based on automated edit checks, manual review, post-hoc data listings, and sponsor requirements


* Maintain all necessary data review documentation to support accurate data cleaning

What You'll Bring:


* Bachelor's degree or equivalent experience in Computer Science/Information Technology or a technical degree in a related field


* 1 years of experience working with databases in a complex clinical data management (CDM) environment, and/or equivalent combination of education and experience


* Database experience with OmniComm TrialMaster or Medidata Rave is preferred

Why CTI?


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