Clinical Trial Administrator II

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cze4a

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? Our team says it’s the best of both worlds….

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.

Main Job Tasks and Responsibilities
- 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 electronic TMF set-up and maintenance during the study, oversight of filing documentation completeness,



through ongoing quality checks and metrics, oversight of CRO filing activities in the eTMF
- 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
- Follows the CRO Awarding Process and handles the invoice process
- Provides input for budget development at Forecast, and Preclosing; 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. May participate, if required, in the Investiga

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cze4a