Updated: Yesterday. Location: Tlalnepantla, MEX, Mexico. Job ID: . Syneos Health is a fully integrated life sciences services organization. We accelerate customer success by integrating drug development and commercialization solutions. This role supports the start‑up of investigative sites across all phases of clinical trials at the country level. Site Activation Specialist I Perform assigned activities to ensure successful site initiation and activation. Work closely with project leads, site teams, regulatory authorities, and other stakeholders to manage timelines, budgets, and quality standards. Job Responsibilities Provide quality deliverables at the country level and follow project requirements and applicable country rules, with oversight from the SSU Country Manager. Monitor forecasted submission/approval timelines, track milestone progress in the agreed SSU tracking system in real time, provide rationale for delays, assist with contingency plans, and promptly escalate issues. Monitor basic financial aspects of the project and hours/tasks available per contract; timely escalation of discrepancies. Review and comply with SOPs and WIs, update training records, and ensure timesheet compliance. Ensure all relevant documents are submitted to the Trial Master File (TMF) per Company SOP/Sponsor requirements. Local Submissions Specialist – follow project direction from the designated country start‑up advisor (CSA) and SAM; act as point of contact for the SAM/PM during start‑up; compile and review essential document packages for site activation; assist with essential document collection from site. Prepare and submit Central EC, Local EC, RA, hospital or other local regulatory authority applications, and ongoing submissions, amendments, and notifications; include safety notifications as required by local rules. Act as liaison between investigational sites and functional leads; facilitate related tasks and/or issues; oversee site activation end‑to‑end at the country/site level. Provide local site ID and feasibility support with site selection lead and PM/SAM to ensure appropriate sites are chosen based on study requirements. Act as Local Investigator Contract and Budget Negotiator – support SAM in agreeing on country template contract and budget, produce site‑specific contracts, negotiate budgets and contracts with site, and assist with quality control and execution of CTAs. Summary Deliver assignments that lead to the start‑up of investigative sites in all phases of clinical trials. Ensure local activities adhere to agreed timelines, budgets, and quality standards. Act as main contact with regulatory authorities and ethics committees under the supervision of the project lead or site activation manager. Additional Information The tasks, duties, and responsibilities described are not exhaustive. The Company may assign other tasks and consider equivalent experience, skills, and education. The Company complies with applicable equal‑employment laws and the Americans with Disabilities Act. Qualifications of incumbents may vary from those listed. #J-18808-Ljbffr