Sr. Site Activation Specialist

Benefits

Additional Information

Sr. Site Activation Specialist Syneos 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. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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. Job Responsibilities Job Summary Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for providing delivery and expertise, with minimal oversight from the Line Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, collection, review and finalization of essential documents required for site initiation and site activation activities. Accountable 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 direction of the Project Lead (PL) or Site Activation Manager (SAM) as appropriate, may directly interact with Customers when receive requirements from RA or other local regulatory party. Accountable to the PL/SAM at the project level and line manager for deliverables. May act as the Country Start-Up Advisor (CSA) or as a line manager / mentor for less experienced staff. At a project level, may act as SAM for local or regional studies. Core Responsibilities - General - 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/SAM. May serve as the primary point of contact for the PM/SAM (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