Sr Medical Scientist - Infectious Disease - HIV

Sr Medical Scientist - Infectious Disease - HIV 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 • Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans. • Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews. Pro-actively identifies and resolves medical data review issues as they arise. Review of SAE reports. • Authors medical data queries and reviews query responses, approves query closure in association with Medical Director. . Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites) •    Responsible for trial design and endpoint development in collaboration with Medical Director •    Sets up/supports SAC, DMC, adjudication committees •    Protocols/amendments – collaborates with medical writer, participates in governance committee review •    Authors protocol clarification letters •    Contributor to study specific documents (e.g., SMP) •    Reviews/updates informed consent •    Provides scientific input to PM for data management activities (e.g., EDC, DRP, CRFs) •    Monitors data issues requiring clinical input •    Monitors central lab reports and other external data for safety and critical values •    Prepares scientific slides, attends and presents protocol information at Investigator Meeting •    Reviews specifications, initiates allocation request form and approval schedule in allocation schedule generation system •    Coordinates planning of lab, bio specimens and imaging specifications •    May co-author newsletters with PM •    Participates in Database lock activities •    Collaboratively plans CSRs and other deliverables with medical writing •    Supports publications/presentations as needed •    Reconciles and review all protocol deviation classifications and periodic reviews •