12/09/2006 SENIOR CLINICAL PROJECT MANAGER - Italy

Job description

Global management of the designated clinical studies, including set-up of the trial, study feasibilities, selection of the sites, start-up, monitoring to ensure satisfactory performance and completion. When necessary, in collaboration with the Data Manager and with the IT Department, design of the e-CRF.
Regular reporting to the Sponsor on study performance, representing the Clinical Monitoring project team in communications and meetings with the Sponsor.
Ensure adequate communication flows and distribute information among the different subjects of the study (Sponsor, Investigators) and within the Clinical Monitoring project team, across all locations and with other departments as appropriate.
Define, develop and implementation of project-specific start-up training of the members of the Clinical Monitoring project team; development and communication of project-specific procedures and guidelines.
Co-ordinate the preparation and updating of all study documentation, including Clinical Trial Master File and Investigator's file.
Qualification assessment, together with the assigned CRAs, of each individual centre; implementation and maintenance of project-specific tracking tools, as required to maintain control of the project activities.
Review of all study documentation, including Case Report Form, to ensure quality and integrity of data, compliance with relevant SOPs and regulatory requirements.
Co-ordinate study drug supply distribution and tracking.
Perform CRA activities, when deemed necessary.
Reporting to Group Project Manager on all project management and clinical monitoring related issues.

• Education: degree in sciences or health-related field or equivalent experience required.
• inimum Work Requirements: Minimum 2 years in a Pharmaceutical, CRO, Biotech or device company.