Sr. Site Contracts Specialist

Benefits

Additional Information

Sr. Site Contracts 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 Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with minimal oversight from the SSU Country Manager.Ensures site contract documentation is in compliance with sponsor and Company requirements. Identifies project and/or country level and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Serves as subject matter expert across all Site Contracts functions.Trains and mentors site contracts staff and proactively identifies ways to improve internal project operations.Establishes strong working relationships with customers, internal project teams and sites. May lead internal team education or process improvement initiatives. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements. Core Responsibilities - May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. - 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 Site Contracts Service Centre and SSUL with Sponsor until resolution of issues. - Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented. - Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. - Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions. - Works closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms. - Works closely with SSU lead, Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog. - Identifies possible contract or process operational risk and proactively works within the team to provide solutions. Establishes strong working relationships with SSU lead, customer and internal project teams. Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department. - Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings. - Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time. - Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues. - Maintains and acti