VUmc Alzheimer Center is seeking a clinical trial manager

In collaboration with VUmc Alzheimer Center, VUmc department of Radiology and Nuclear Medicine performs high quality research on dementia, in particular with the use of Positron Emission Tomography (PET) imaging. Led by VU University Medical Center Amsterdam , the AMYPAD consortium brings together a word-class team of highly synergistic partners from across Europe to form a pan- European network including the most active PET sites. They are 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 their industrial partners. He or she will be in charge of preparing sites for their local ethical and regulatory submissions and liasing with the Clincial Research Organization (CRO) for training sites and resolving queries. Furthermore, he or she will serve as the main point of contact between researchers, acamedic sites, industrial partners, and the Sponsor.

As a Clinical Trial Manager your most important tasks and responsibilities are:

Managing ethical and regulatory authority applications and approvals across participating trial study centers;
Identifying/selecting new trial study centers and investigator responsible for conduct of the study at site;
Setting up trial study centers in collaboration with CRO;
Liasing with researchers and CRO on trial study conduction;
Setting up and maintaining Trial Master File / archiving study documentation and correspondence;
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.

The candidate should meet the following requirements:

Experience with conducting Clinical Trials in Europe;
Good communication skills in English (written and oral);
Good organizational and managerial skills are a must; project management certification is a plus;
Experience with multicenter studies in the context of Alzheimer’s disease and/or PET imaging is a plus.

If you are interested, more information are available here.