Clinical project Leader – international role/
2013-01-10
Our client Pharmaceutical Company is currently recruiting individuals for Prague office. Clinical Project Leader will be responsible for medical device studies, managing CRO activities in relation to clinical studies conducted in a European context.
This is a lead/senior role and you will be responsible for study management and monitoring activities:
-Preparation of clinical protocols, contract amendments
-Preparing of clinical reports and data analysis.
-Manage selection and initiation of clinical sites including Ethics Committee submissions and applicable study training including protocol and e-CRF.
-Managing monitoring and reporting site enrollment progress including device accountability in registration studies.
-Collecting completed Case Report Form (CRF) and collecting, confirming and auditing supporting documentation.
-Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements.
Ideal candidates will have minimum of 5 years experience (Senior CRA) in clinical research. Experience in medical device regulatory documents/adverse events reporting and handling.
Strong project Management and leadership skills, willingness to travel (Germany and to Switzerland).
We offer to working in international company total rewards package which includes competitive compensation, excellent benefits, and career and development opportunities.
In case of interest please send your CV to Lucie Ondruchová at ondruchova@hays.cz
