Job Description**Please note this role can be based remotely from locations across SpainThe Study Start Up CRA is accountable for site selections as well as study specific start up activities and deliverables of assigned sites for Phase I IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs.Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).Accountabilities Supports country SSU strategy in close collaboration with SSO Study Start Up Team Lead, SSO Study Start Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager Collaborates with SSO Study Start Up Manager, SSO Study Start Up Team Lead and global study team to ensure Study Start Up timelines and deliverables are met according to country commitments Accountable for timely start up activities from country allocation until site greenlight at assigned sites Conducts site selection visits, verifies site eligibility for a specific study Main contact for trial sites during site selection, study start up and IRB/IEC and HA submission preparation Ensures that milestones (KPIs) and time schedule for study start up are met as planned Facilitates the preparation and collection of site and country level documents Collects submission relevant site specific documents (e.G., FD, CV, GCP certificates, DSL...) for all relevant site personnel within agreed timelines Supports SSU Manager in preparation of country specific documents, e.G., ICF, patient facing materials, etc. Supports SSO Study Start Up Manager and assigned sites in vendor set up activities Prepare and finalize site specific documents for submission Negotiates investigator payments as needed Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed Updates all systems until site Green Light on an ongoing basis Supports preparation of audits and inspections as applicable Supports reduction of formal site specific IRB/IEC deficienciesCommitment 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 requirementsSkills and Experience Required A degree in scientific or health discipline, preferably with clinical operations experience Minimum 3 years experience in clinical operations in a monitoring / site management role Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set up, execution, and monitoring Central/in house monitoring or field monitoring experience is desirable Fluent in both written and spoken English, local language as neededDivisionGlobal Drug Development Business UnitGCO GDD CountrySpain Work LocationMadrid Company/Lega