The Amsterdam UMC location VUmc is recruiting a Clinical Trial Manager for the AMYPAD Prognostic and Natural History Study (PNHS).
This study involves 17 sites in 8 countries across Europe. Due to the size of the study, the sponsorship role entails continuous communication with several academic and industrial parties, requiring excellent communcaiton skills and a good eye for detail. Therefore, VUmc is looking for a qualified Clinical Trial Manager to support the Sponsor in ensuring good conduct of the study across participating sites. The primary responsibility for the Clinical Trial Manager will be managing the study within the Consortium and in collaboration with the industrial partners. He or she will be in charge of preparing sites for their local ethical and regulatory amendment submissions and liasing with the Clinical Research Organisation (CRO) for training sites and resolving queries. Furthermore, he or she will serve as the main point of contact between researchers, academic sites, industrial partners, and the Sponsor.
As a Clinical Trial Manager your most important tasks and responsibilities are:
- Preparing necessary protocol amendments and managing ethical and regulatory authority applications and approvals across participating trial study centers;
- Contract review and negotiation;
- Liaising with researchers, study sites and CRO on trial study conduct;
- Maintaining Trial Master File and periodic review of Investigator Site Files;
- Updating/maintenance of SOPs and training documents;
- Support pharmacovigilance reporting in collaboration with industrial partners;
- Preparing reports for ethical committees and regulatory authorities;
- Serving as primary contact for investigators; coordinating all correspondence; ensuring timely transmission of clinical data with the study site and technical reporting, as requested;
- Assisting with and attending Investigator Meetings;
- Host/chair weekly study update meetings;
- Managing invoices from study sites;
- Data management and query resolution.
The position will be for four to seven months (depending on contract hours) to cover Maternity leave period. The desired start date is 1 August 2020. Interviews will take place in the week of 13th of July.
If you’re interested about this position, you can contact Isadora Alves Lopes (Project Manager), or Ifrah Iidow (Clinical Trial Manager), via telephone number +44 7487 712219.
You can apply till 8 July 2020 by visiting this link.