Sponsor Dedicated Sr Site Activation Specialist (1 Year fixed term) - Home Based ITAUpdated: January 3, 2025Location: Italy-Europe - ITA-Home-BasedJob ID:24007104Sponsor Dedicated Senior Site Activation Specialist (1 Year Fixed Term) - Home based ITAPrevious experience with Gene therapy studies is required.Syneos 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.Why Syneos HealthWe 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 our Total Self culture – where you can authentically be yourself.We are continuously building the company we all want to work for and our customers want to work with.Job responsibilitiesResponsible for quality deliverables at the country level; follows project requirements and applicable country rules, with minimal oversight from the SSU Country Manager.Forecasts submission/approval timelines, ensures compliance and tracks milestone progress in agreed upon SSU tracking system in real time.Monitors financial aspects of the project and the number of hours/tasks available per contract.Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner.Ensures continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned.Responsible for one or more of the following functions at the country level:Local Submissions Specialist - Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and PM/SAL.May serve as the primary point of contact for the PM/SAL during start-up on allocated projects.Oversees ongoing submissions, amendments, and periodic notifications required by central and local EC and RA.May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues.QualificationsBachelor's DegreeExcellent understanding of clinical trial process across Phases II-IV and ICH GCPGood understanding clinical protocols and associated study specificationsExcellent understanding of clinical trial start-up processesProject management experience in a fast-paced environmentStrong organizational skills with proven ability to handle multiple projectsExcellent communication, presentation and interpersonal skillsQuality-driven in all managed activitiesStrong problem-solving skillsAbility to mentor, lead and motivate more junior staffAdditional Information:Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
The Company may assign other tasks, duties, and job responsibilities at its discretion.At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace.
If your past experience doesn't align perfectly, we encourage you to apply anyway.Syneos Health is an Equal Opportunity Employer.
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