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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.