.Local Clinical Trial Manager - Sponsor DedicatedApply locations: Madrid, SpainTime type: Full timePosted on: Posted 2 Days AgoJob requisition id: R1441865Services Overview:Local Trial Management services provide local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Site Manager (SM), and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.Deliverables:- Services rendered will adhere to applicable sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.- Complies with relevant training requirements.- Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report.- Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget.- Act as primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed.- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.- Contribute to site level recruitment strategy and contingency planning.- Delivers competent vendor management at the country level to support the study.- Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed.- Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent.- Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines.- Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management.- Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.- With focus on quality and compliance, will work closely with SM to ensure CAPA is implemented for audits/inspections.- Ensure accurate finance reporting and trial delivered within budget.- Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals