.Site Activation Specialist with experience in Chile - home based Argentina, Chile or MexicoUpdated: September 25, 2024Location: Mexico-Latin America - MEX-Home-BasedJob ID:24004238Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Job responsibilitiesResponsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate 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 timelinesare not reached: investigates and provides clear rationale for delays, provides support on 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 discrepanciesin a timely fashion.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 quality 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 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 SAL. May serve as a point of contact for the PM/SAL (or designee) during start-up on allocated projects. Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required