Study Start-up

hace 1 semana

Barcelona, España Novartis A tiempo completo

**Job purpose** In close collaboration with the Country trial Responsible, the SSU-CRA is involved in the strategic selection of study sites by verifying the site's eligibility for a specific study. The SSU-CRA performs study specific start-up activities and site selections of Phase I-IV GDD and NIBR trials. The SSU-CRA is responsible to set-up study sites within timelines and required quality standards in accordance with ICH-GCP, local regulations and SOPs.**Major Accountabilities** - Conducts site selection visits - Screens potential investigators and networks to evaluate capabilities for conducting clinical trials - Main contact for trial sites during site selection and study start-up. - Regularly contact for strategic alignment with CSM, CSE, Trial operations, Feasibility managers and Field Monitors. - Ensures that milestones (KPIs) and time schedule for study start-up are met as planned - Ensure the collection of Ethic/Submission relevant documents (e.g. FD, CV, GCP certificates, others) for all relevant site personal within the respective timelines - Negotiates investigator remuneration as needed; supports preparation of financial contracts between Novartis and investigational sites and investigators. - Site handover to Field Monitor - Accountable for continuously updating all electronic systems (global and local) relevant until handover for site initiation - Time recording activities according to Novartis internal processes and systems (e.g. Horizon) - Develops personal skills and continuous educational development in accordance with Clinical Function Head TMO/DUH/CRA manager - Performs additional tasks as assigned - Participates in or leads multi-disciplinary teams within CPO and globally (eg. RE) to evaluate and implement process improvements as well as strategical initiatives that could help to achieve main TMO objectives, vision and purpose. - In close collaboration with Feasibility Manager and CSM decide the strategic selection of study sites. - Identify and qualify new potential sites to be more effective to conduct clinical trials. **Commitment to Diversity & Inclusion**: - Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._ **Minimum requirements** **Education**: Degree in scientific or healthcare discipline.**Languages**: Fluent in both written and spoken English and Spanish**Experience** Proven excellence and experience in all aspects of monitoring and site management (> 3 years) **Division** - Global Drug Development **Business Unit** - GDO GDD **Country** - Spain **Work Location** - Barcelona **Company/Legal Entity** - Novartis Farmacéutica, S.A. **Functional Area** - Research & Development **Job Type** - Full Time **Employment Type** - Regular **Shift Work** - No **Early Talent** - No

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