Sr Site Activation Specialist

Description Sr Site Activation Specialist 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. 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. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.Responsibilities Responsible 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; if forecasted timelines are not reached analyses data to provide clear rationale for delays, provides contingency plans to mitigate impact, and escalates the issue as soon as identified. Monitors 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 (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements. Ensures 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.). May be involved in vendor management. 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 (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. Oversees 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 minimal 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. Country Start‑Up Advisor - Acts as Subject Matter Expert for in‑country performance within the Site Start‑Up. Local Site ID and Feasibility Support - Provides support site selection lead and PM/SAL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.Local Investigator Contract and Budget Negotiator - Produces site‑specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site‑specific contracts from country template. Submits proposed CTA and investigator budget for site review. Negotiates budget and contract with site and via SiteSite Activation Specialist I Syneos - Clinical and Corporate - Prod DescriptionSite activation Specialist ISyneos 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... Contractor, Sr. Specialist, Marketing PTC THERAPEUTICS Job Description Summary:Job Description:The Sr. Specialist, Marketing is responsible for the development, implementation and management of specific marketing projects for the South Cone region. This position, works closely with the Global Marketing team.The incumbent works... Site Contract Spec PPD - We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. 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Sr Clinical Trial Manager Syneos - Clinical and Corporate - Prod DescriptionSr Clinical Trial ManagerSyneos 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... #J-18808-Ljbffr