Clinical Trial Administrator II

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Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? ClinChoice is searching for a Clinical Trial Administrator to join a pharmaceutical company
ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counterparts.
Prepares/assembles study documentation, including submission package to Regulatory Authorities and Ethics Committees, study documents prepared through EDMS, reviews English texts and translations, and is in charge of formatting study documents, such as study protocols, clinical study reports, etc.
Responsible for eTMF and paper TMF reconciliation after study completion
Participates in the completion and review of Requests for Proposals sent to CROs in collaboration with the Clinical Project Manager




checks monthly costs invoiced to the Sponsor based on planned study activities vs actual through our dedicated tool and ensures that invoices received are as expected; manages the Investigator Fees reconciliation and supports the Clinical Project Manager in all activities related to budget operations
Organizes and participates in Kick Off Meetings, Study Design Meetings, and phone conferences with the CROs for continuous updates on clinical studies. Collaborates with the Clinical Project Manager with corrective and preventive actions, in case of deviations and following audits
Assists the eCTD team in the formatting of all documentation related to a clinical study, aimed at obtaining an electronic copy of the registration dossier
Education and Experience
Bachelor's degree
Experience in clinical research or the healthcare-related industry, including as a Clinical Trial Assistant
Working knowledge of international regulatory and

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7emqrl