Clinical Programmer

🕒 vor 2 Monaten

🐎 Kentucky – Remote

🐎 Kentucky – Remote

⏰ Vollzeit

🟢 Junior

🖥 Softwareentwickler

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CTI Clinical Trial and Consulting Services

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1001 - 5000 Mitarbeiter

Gegründet 1999

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

CTI Clinical Trial and Consulting Services ist eine Full-Service-Auftragsforschungsorganisation (CRO), die klinische Studien, regulatorische Strategien, Labor- und bioanalytische Dienstleistungen, Generierung von Evidenz aus der realen Welt und Forschungszentrum-Management für Biotech- und Pharmaunternehmen anbietet. Mit Expertise über die Phasen I–IV und in komplexen therapeutischen Bereichen (einschließlich seltener Erkrankungen, Zell- und Gentherapie, Onkologie, Neurologie und Transplantation) unterstützt CTI das Studiendesign, das Standortmanagement, die Patientenrekrutierung, das Monitoring, die Sicherheit/Pharmakovigilanz, die Biometrie und die Qualitätssicherung. Mit Hauptsitz in Covington, KY, legt das Unternehmen Wert auf integrierte, patientenzentrierte Ansätze und globale regulatorische Beratung, um die Entwicklung zu beschleunigen und Therapien zu den Patienten zu bringen.

Beschreibung

• 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. • 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. • 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.

🎯 Anforderungen

• 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

🏖️ Vorteile

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. • We also value ongoing education and training through tuition reimbursement and a dedicated training department. • Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. • We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. • We also encourage care for the world around us through our unique CTI Cares program.