| Line Manager | Coordination Center of INCIPIT (key reference roles: Senior Scientific Managers) |
| Principal Accountabilities | To provide support to the general activities handled by the INCiPiT Coordinating Center Team, in terms of: – Financial tracking (invoicing, finalization of Work Orders, ad hoc contracts, tracking of the administrative activities of the NHs involved in the c4c project/studies) – Tracking of the agendas of pre-defined meetings/commitments and organization of ad hoc meetings, as per specific Team involvement – Distribution of materials to Operative Teams, Study Teams and or Scientific Teams – Support the activities of INCiPiT Working Groups, as requested – Support the interactions with local INCiPiT referees, also to retrieve specific information. – Bridging with CROs and/or Sponsors to support specific activities, such as: study scientific/operational feasibilities, identification of local costs and finalization of study budgets, identification of the local correct stakeholder for contract negotiations. – Support the internal CRAs and/or the Clinical Project Manager (CPM) in performing the regulatory mapping for a clinical study/clinical project – Supervise the flow of regulatory documentation from the NHs to the allocated vendor for TMF/ISF management (therefore to supervise the specific activity when allocated on the internal regulatory resource) – Perform directly any regulatory submission (when requested by the Sponsor) and maintain contacts with Regulatory Authorities and/or Ethics Committees. |
| Professional Background and Experience | – Scientific Degree in Science – Research or health care related academic or work experience – From 2 to 3 years of experience in Clinical Trials coordination and or Clinical Development activities and a minimum of one (I) year of administrative experience (or equivalent training) |
| Technical Competencies | – Knowledge of GCPs and of Regulatory/ethics obligations, laws and regulations for clinical trials/clinical development management – Very good Knowledge of the main Office software (Word, Excel, Power Point, etc.) – Capability to get quick familiarity with CTMSes and databases, research dedicated – Good knowledge of quality systems and quality assurance assets |
| General Competencies | – Professional Knowledge of English, both spoken and written – Very good organizational skills, ability to manage multiple tasks and meticulous attention to detail – Very good time management skills – Very good written and verbal communication skills – Advanced ability and attitude on team working ad in particular good capability to work in a matrix environment |
| Salary | To be discussed during the interview. Benchmarking with the present position as defined in academic organizations is proposed. |