Job Description
Job purpose
At Blue Earth Diagnostics, which is part of the Bracco Group, our mission is to transform the clinical management of patients with cancer by developing innovative molecular imaging technologies. Our team is made up of industry leaders in the field of radiopharmaceutical development and commercialization. Blue Earth Diagnostics is a dynamic and growing company with an approved product already on the market in the USA and in Europe, and a development pipeline of diagnostic radiopharmaceuticals.
The Clinical Trial Administrator (CTA) is responsible for supporting the Clinical Trial Manager (CTM) and wider Clinical Operations team for their assigned projects. This position is fundamental to the efficient execution of trials and supports overall compliance with Good Clinical Practice (GCP) and company Standard Operating Procedures (SOP’s).
Main Responsibilities, Activities, Duties and Tasks
1. Set-up, prepare, handle, distribute, file and archive all essential and supportive clinical study documentation within the TMF (Trial Master File; paper or electronic), and be the point of contact for all queries on the assigned TMF(s).
2. Responsible for periodic reviews of the study files for completeness.
3. Support the assigned studies by maintaining adequate tracki...