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Trabajador de Lavandería • San Vicente del Raspeig
Descripción del trabajo :
Planet Pharma is partnered with a global, full-service Contract Research Organization (CRO), who are currently hiring for a Clinical Study Builder on a fully remote basis.
Main Responsibilities :
* Collaborate with data management and statistical teams to design and develop electronic case report forms (eCRFs), visit schedules, and data quality checks.
* Implement, test, and integrate systems to support medical research studies.
* Primarily build CRFs using Veeva CDMS, with possible work on Medrio or Rave EDC systems.
* Ensure compliance with regulatory requirements, industry guidelines, and Innovaderm's standard operating procedures (SOPs).
* Adhere to sponsor requirements and project timelines while maintaining high-quality standards.
* Set up Coder, Local Lab, and Targeted SDV modules for clinical studies.
* Lead eCRF design and review meetings to ensure study requirements are met.
* Provide user and technical support, including troubleshooting and timely issue resolution.
* Conduct end-user training on system functionalities and processes.
* Collaborate closely with Lead Data Managers to optimize data collection and management.
* Work with vendor partners to support testing and deployment of clinical study systems.
* Assist in defining, writing, and updating Veeva CDMS SOPs to maintain compliance and efficiency.
Main Requirements :
* B.Sc. or M.Sc. in a related field.
* Minimum 2 years of experience in Veeva CDMS study build.
* Experience with Medidata Rave build is a plus.
* Strong expertise in case report form (CRF) design and database programming.
* Ability to manage multiple study builds and post-release changes simultaneously.
* Understanding of the drug development process and regulatory guidelines (Good Clinical Practices, ICH).
Interested? Apply now for immediate consideration or contact Maria Tsalpatourou.
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