RegulatoryandStartUpSpecialist-Italy

_**Job Overview**_ Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. __**Hybrid role to be in office monthly based in Milan. Experience with local submissions and fluency in Italian.**__ _**Essential Functions**_ * Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. * Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. * Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. * Distribute completed documents to sites and internal project team members. * Prepare site regulatory documents, reviewing for completeness and accuracy. * Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. * Review and provide feedback to management on site performance metrics. * Review, establish and agree on project planning and project timelines. * Ensure monitoring measures are in place and implement contingency plan as needed. * Inform team members of completion of regulatory and contractual documents for individual sites. * Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines. * Provide local expertise to SAMs and project team during initial and on-going project timeline planning. * Perform quality control of documents provided by sites. * May have direct contact with sponsors on specific initiatives. **Qualifications** **Bachelor’