Site Id Specialist

Site Id Specialist (English Advanced Required) Syneos - Clinical and Corporate - Prod Description Site ID Specialist (English Advanced 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. 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 Acts as primary contact to the Site Identification Lead in an assigned country/region for awarded or ongoing trials. May also act as primary contact to pre-award team for blinded site level feasibility performed in response to a Request for Proposal. Utilizes local knowledge and relationships to contribute to the local country and site plan for the study (number of sites proposed, type of sites, recruitment rates, competitive studies and key challenges). Validates feasibility/site ID assessment during the study and supports the preparation of the final feasibility report by collecting site level feasibility data from potential sites. Acts as primary contact to the investigational sites and study staff to collect and QC data from feasibility surveys, includes the tracking and documentation of such activities into the Syneos Health Investigator database and interaction with internal study team members as required. Builds local relationships with key research sites and Key Opinion Leaders. Leads the collection and review of country specific historical site/investigator experience data and data entry in to a centralized Syneos Health Investigator database. Performs searches of external data sources to identify additional investigators to build the database. Performs review of regulatory sources to determine if regulatory actions exist against investigators. Documents and shares any findings with the study team. Conducts validation and verification checks of site/investigator contact details for the purposes of finalizing a Site/Investigator list for a planned study. Distributes and collects privacy notice and consent forms, confidentiality agreements, potential investigator questionnaires, and other site identification documents (e.g. protocol synopsis) to potential study sites. Liaise with representatives from Site Contract Service Center during site confidentiality agreement negotiations. Supports Site Identification Lead (SIL) with preparation and documentation of corrective and preventive actions associated with quality issues. Communicates compliance and performance to relevant stakeholders as appropriate. Ensures submission of site identification related documents to the dedicated project file in the collaborative workspace/trial master file and manages Study Specific folders in accordance with the corporate and project specific processes. May contribute to the administration and maintenance of the global investigator database. May assist with other clinical systems enhancements/projects as necessary to meet business needs. Serves as back-up for colleagues, when required. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. #J-18808-Ljbffr