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Clinical Operations Lead

External
alimentiv-2 logoAlimentiv-2 · Budapest, Hungary
Full-timeRemote18mo ago
DocumentationGCP
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Requirements

  • College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
  • Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training

Additional Information

Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team. Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain "@alimentiv.com", to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender's email address and that they are asking you to apply on this website. If you believe you've been a victim of a phishing scam, please contact your local government cyber authority to report.


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