Site Activation Specialist for BRA sites - English and Portuguese Advanced - Hybrid in Buenos AiresSyneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.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 deliver - for one another, our customers, and, most importantly, for those in need.Discover what your 25,000 future colleagues already know:Why Syneos Health- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.- We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.- We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Responsibilities:Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for the delivery,



with oversight from the Line Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs) under the supervision of the Project Lead (PL) or Site Activation Manager (SAM) as appropriate, may directly interact with Customers regarding requirements from RA or other local regulatory party. Accountable to the PL/SAM at the project level and line manager for deliverables.Core Responsabilities- This role will provide support to sites in Brazil- 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 SAM. May serve as a point of contact for the SAM/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 Central EC Applications, 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 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 oversight from the SSU Country Manager.- May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/ site level.- Local Site ID and Feasibility Support - Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of

📌 Site Activation Specialist for Bra Sites - English and Portuguese Advanced - Hybrid in Buenos Aires
🏢 Syneos - Clinical and Corporate - Prod
📍 Buenos Aires