الوصف الوظيفي
Work ScheduleSecond Shift (Afternoons)Environmental ConditionsOfficeJob DescriptionSr Clinical Trial Coordinator (Sr CTC)Minimum Education and Experience: + Bachelor’s degree or equivalent experience with minimum three years relevantexperience. Roles/Responsibilities: + Analyzes and reconciles study metrics and findings reports. + Assists with clarification and resolution of findings related todocumentation according to the specific role (central or local), coordinates,oversees and completes functions on assigned trial activities. + Completes file reviews/completeness checks based on client requirementsto ensure TMF inspection readiness. + Uses critical thinking to ensure tasks are proactively scheduled and fulfilledin line with project team needs. + Proactively communicates any risks to project leads and line manager asappropriate. + Supports the maintenance of study specific documentation and globalsupport with specific systems, tools and trackers, including, but not limitedto, study team lists, tracking of project specific training requirements,system access management for organization/vendor/clients, and tracking ofproject level activity plans in appropriate system(s). + Ensures (e)TMF is up to date by following file review schedules anddocuments findings in appropriate system(s). + Reviews and tracks local regulatory documents. Supports project team toensure audit readiness, (e.g., [e]TMF) and contributes to internal, regulatoryand client audit responses as needed. + Provides system support (e.g., Activate and eTMF) and ensures systemsdatabases are always current. + Maintains knowledge of and understands SOPs, client SOPs/directives, andcurrent regulatory guidelines as applicable to services provided. Ensures that trial status information relating to activities are accuratelymaintained in the database and is always current. + Trains new personnel on processes and systems. + Contributes todiscussions with teammates in other regions to support a collaborativenetwork with consistent processes and sharing of best practices. + Provides training to other functional team members. + Serves as analliance-level lead, handling client (e)TMF activities. + Provides technical and administrative support and coordination forprojects in collaboration with relevant internal departments and teammembers.+ aggregate & analyse TMF-related data in BIs TMF System & related tools
