Sr Medical Scientist

Overview Sr Medical Scientist (Location: Argentina, Chile, Guatemala, Peru, Costa Rica) 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 places the customer and the patient at the center of everything we do. We continuously seek to simplify and streamline our work to make Syneos Health easier to work with and 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. 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. Proactively identifies and resolves medical data review issues as they arise. Authors medical data queries and reviews query responses, approves query closure in association with Medical Director. May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed. Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed. Manages project scope of work, objectives, and quality of deliverables to ensure the project-specific milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review. Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management to identify risks related to data integrity and subject safety. Escalates ongoing and newly developed study concerns in a timely manner. Attends and presents at Trusted Process meetings and may participate in internal and external audits. Maintains a basic understanding of ongoing protocol designs and disease terminology and pathology. Adheres to data privacy guidelines, ICH and GCPs, all enterprise policies, SOPs, work instructions, and project plans; adheres to customer policies as required. May manage a limited number of direct reports or participate in interviews. Summary of responsibilities is focused on collaboration with Medical Director to ensure scientific integrity and data quality of clinical trials through data reviews and medical management activities. 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. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Partners with Medical Director to provide clinical and scientific input to early and late-stage clinical development programs with an emphasis on protocol-specific requirements and ensuring the scientific integrity and data quality of clinical trials by using scientific knowledge. Collaborates with Medical Director(s) and other team members on data reviews, and other Medical Management activities to ensure the successful execution and conduct of clinical trials. #J-18808-Ljbffr