.DescriptionSenior Clinical Research Scientist 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 brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us 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 EVERYWHEREWhy 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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.Job responsibilities Acts as a scientific consultant and provides scientific and regulatory support to clients and internal teams.Provides scientific support/strategy on highly complex study designs.Plans and develops Early Phase study designs/synopses/protocols and related documents, as well as all related quality control activities.Participates in reviewing Early Phase protocols prepared by clients.Participates in reviewing project documents prepared by other internal teams (e.G., SAP, Clinical Study Report, etc.).Accountable for scientific leadership and deliverables on assigned activities throughout project conduct.Creates/reviews Standard Operating Procedures (SOPs).Actively participates in regulatory monitoring/intelligence; prepares, revises and updates scientific databases (e.G., Scientia) used by other internal teams.Keeps track of assigned documents/deliverables until the end of the study, and delivers within required timelines; addresses and manages related issues.Independently prepares and presents scientific material at internal and client calls.Synthesizes and integrates into the documents (e.G., protocols) comments made by clients, internal stakeholders, the ethics committee and regulatory agencies (pre and post study).Participates in bid defense meetings
