Klinischer Monitor, Start-Up Manager, PM/CM

11/2012 – 12/2014

Start Up Manager
Managed and coordinated the start-up of clinical trials in Europe.
Identification and recruitment of potential investigators, collection of investigator documentation, and site management in Europe.
Responsible for submitting the required investigator and regulatory documents for a study including their creation, review and adaption to ensure that the documents meet the specifications required by local regulations, Medical Device Directive, ISO14155 and/or the study sponsor
Management and coordination of people involved in start-up activities
Primary contact with investigative sites during start-up activities
Negotiation and finalisation of investigator contracts and budgets
Follow-up on regulatory submissions to EC and CA until final approval
Ensure compliance is maintained within applicable regulatory legislation

Senior CRA
 Management of 2 clinical sites in France in the field of haematology (IVD)
 Management of 3 clinical sites in Germany in the field of breast reconstruction

Kundenberatung, Medizin

5/2009 – 10/2012

 Management of a team of 4 people
 Management of complaint handling and vigilance reporting, FSCA management
 Product registration
 Review and approval of general A&P material
 Companies representative with the French trade union SNITEM

Medizin