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Clinical Data Reviewer (Oncology – North America or UK Only) 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 Open to Canada, US, and UK — with no sponsorship needs.Oncology experience required The Clinical Reviewer (CR) is a specialized role that performs clinical review, typically ahead of significant project milestones (interim analysis, study closeout, submission etc.). The studies supported by the CR are often, but not exclusively, comparative safety and efficacy (Phase 3) trials with large, multi-faceted data sets.Thereview tasks performed by this role include both point-to-point clinical review checks and interpretive analysis such as reviewing data for submission, highlighting errors, raising queries etc. from a clinical perspective.The CR will work as an extension of the clinician/clinical scientist and will be responsible for the clinical review of one or more studies with the ability to move easily from project to project as necessary. Job Responsibilities:Ensure data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publicationsReview participant level data across a study in adherence with CRF Completion guidelines (CCGs) and the Data Review Plan (DRP)Conduct point-to-point data checks (e.g. verifying the presence of a lab test that satisfies study inclusion criteria) and interpretive analysis (e.g. reviewing to identify inconsistencies in the participant’s data).Generate queries on discrepant data and follow to resolution including escalation of issues that cannot be resolved through the query processCreate and use data review best practices and associated data review tools to identify trends and any safety signalsMay identify protocol deviations during routine clinical review and escalation as appropriateFollow relevant SOPs and regulations, have an excellent understanding of and comply with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical proceduresMay liaise with data management, clinical and site management along with other members of the study teamAttend Clinical Meetings and Study Meetings, as necessary At Syneos Health, we
