Consorzio per Valutazioni Biologiche e Farmacologiche is looking for graduates in statistics or scientific relevant fields for a position of Clinical Data Manager.
Description
The Clinical Data Manager, in the framework of clinical trials carried out by CVBF as sponsor/CRO, will have the responsibility to handle data collected through the study e-CRF (either paper or electronic), in order to ensure their accuracy, reliability and completeness, participating actively in the management, administrative and coordinating activities of multicenter and multinational clinical trials.
In particular he/she will be responsible for:
- Participating in the review of clinical research documents (eg. Protocols, study manuals, clinical reports)
- Developing and managing of the DMP ( Data Management Plan)
- Designing the paper data report forms (CRF)
- Activating and maintaining contacst with the tools suppliers of EDC (Electronic Data Capture)
- Participating in the data reconciliation activities
- Carrying out training activities for the compilation of electronic and paper CRF
- Carrying out the cleaning and recoding of clinical data
- Coordinating the activities of the UAT (User Acceptability Test) in the development of the electronic CRF
- Managing the closing of the database and the data transfer
Qualifications
- University degree in statistics or scientific relevant fields
- Excellent knowledge of clinical research (GCP, GMP, etc.), methodology of clinical trials, rules for the compilation of CRF, data management procedures as well as the clinical trials legislation
- Experience of at least four years as data manager Proficiency in English (spoken and written)
Type
Permanent work
Entry level and salary
I Level, CCNL
Job location
Pavia (Italy)