DescripciónJob responsibilitiesResponsibr the deliverables at the country levellows project requirements and applicable country rules, with moderate oversigom the SSU Country Manager.Works within trecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; recasted timelines are not reached:Investigates and provides clear rationar delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.Monitors basnancial aspects of the project and the number of hours/tasks available per contract; escalates discrepanciesin a timeshion.Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.Supports continuous improvement of in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).Ensure all relevant documents are submitted to the Trial Mastle (TMF) as per Company SOP/Sponsor requirements.Responsibr one or more of tllowinctions at the country level: Local Submissions Specialistllows the project direction provided by the designated country start-up advisor (CSA) and SSUL. May serve as a point of contar the PM/SSUL (or designee) during start-up on allocated projects.Complies and/or reviews essential document packagr site activation and may also be involved in essential document collectiom site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversigom the SSU Country Manager.We're lookirBachelor's Degree,Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.Ability to understand clinical protocols and associated study specifications.Detailed understanding of clinical trial start-up processes.Ability to manage rnal vendors to contract effectively.Strong organizational skills with ability to handle multiple tasks effectively.Strong written and verbal communication and interpersonal skills.Ability to manage multiple project budgets with increased complexity and value.-driven in all managed activities.Good negotiating skills.Good problem-solving skills.Demonstrated ability to work independently as well as part of a team.Categorías: Sector saludInvestigación clínica - MédicaID:14685625Reportar Vacante