Support the Global Study Manager (GSM) in all aspects of operational planning, management and execution of clinical studies and program(s) within Trial Operations • Support the GSM performing budget management activities such as grant plan requests, local study cost request, validate and track invoices, prepare reports and analytics and perform the final budget reconciliation·         Responsible for the distribution of Protocol, SIS/ICF and any essential Study Documents. Responsible for the kick off meeting organization. Provide support with the Clinical Trial Application (CTA) preparation·         Liaise with the Vendor Managers, providing study specific information to facilitate proposals, budgets and technical specifications.  Participate in regular vendor meetings; escalate issues for resolution, review & reporting·         Coordinate Clinical Study Team (CST) meetings. Prepare minutes and follow-up actions. Prepare, compile and distribute study status reports·         Own the development, preparation, distribution and update of study plans and documents·         Prepare study training materials, organize and conduct global FTF or virtual Investigator Meetings·         Review audit responses. Support Deviation management process, e-TMF, CSR appendices

- eTMF Maintenance for the studies managed- Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager.Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified. Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.Responsible for one or more of the following functions at the country level:Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SSUL.  May serve as a point of contact for the SSUL/PM (or designee) during start-up on allocated projects.  Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.Prepares and submits Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision.  Prepares ongoing submissions, amendments, and periodic notifications required by local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with overight from the SSU Country Manager.

- Support to the team as a Clinical Trial Assistant, providing trainings to the team related to File Management and also acting as CTA for the studies assigned and supporting others with their files.-Wingspan Champion for SSU and Maintenance Regulatory teams.-Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations working closely with the Site Activation Manager, Project Management team, and other departments as necessary. -Review documents for completeness, consistency and accuracy, under guidance of senior staff.-Prepare site regulatory documents, reviewing for completeness and accuracy.-Inform team members of completion of regulatory and contractual documents for individual sites.-Distribute completed documents to sites and internal project team members.-Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.-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.

•Perform administrative tasks •Prepare, distribute and file clinical documents and reports•Review of study files periodically to ensure completeness and audit readiness•Management and maintenance of Sponsor's specific clinical systems•Assisting Clinical Team Managers and CRAs•Update and maintenance of clinical systems•Act as a central contact for the clinical team for project communications•Maintenance and reconciliation of study/site Master Files according to SOPs

•Clinical Trial Assistant tasks with half workload than a fulltime assistant.•Perform administrative tasks •Sending documents for translation (use of specific platforms) and review once ready •Document upload in databases •File reviews •Assistant for other team members as required •Document review and naming

•Review of patent translations•Translation of small texts as per company's requirements •Group collaboration to achieve timelines and milestones•Image and text edition