Clinical Trial Manager - Sponsor Dedicated

Job Title: Clinical Trial Manager - Sponsor Dedicated Job Location: Sao Paulo, Brazil Job Location Type: Home-based Job Contract Type: Full time Job Seniority Level: Clinical Trial Manager – Sponsor Dedicated. Clinical Project Management services provide management of a clinical trial (s) in a local level. Services/deliverables include operational oversight of assigned project(s) at the local level for end-to-end project management from start-up through to closeout activities. Tasks & Responsibilities: Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements. Prepares or contributes to high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensures overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract. Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve c