Sr Clinical Research Scientist

Job Description

*Senior Clinical Research ScientistCome discover what our 25,000+ employees already know: work here matters everywhere. We re a growing and evolving biopharmaceutical industry leader, which means you ll have endless opportunities to work with experts around the world and build the career you ve dreamed of. As a part of the Syneos Health team, you ll help us deliver results for a rewarding reason we improve patients lives around the world. Because to us, a patient isn t just a number, they re our family, friends, and neighbors.Why Syneos Health #SyneosHealthLife means we re committed to our Total Self culture where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person s unique contributions make a difference. We believe our success is a direct result of the people who are driving it you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. 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. Ensures that study designs are adequate and meet study objectives while ensuring subject safety. 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). May prepare communications intended to regulatory agencies to ensure the feasibility and compliance of clinical trial applications at the regulatory level. Participates in bid defense meetings Develops strong relationships with current clients to help generate new and/or add-on business for the future. Train, support and coach junior team members. Facilitates team training in accordance with design/project/regulatory/process requirements., *What we re looking for Master s Degree (or equivalent) level of qualification in life science. Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process, literature research. Clinical research organization (CRO) preferred. Strong ability to manage time and work independently. Must demonstrate good computer skills especially in the utilization of Microsoft Word, Excel, PowerPoint, and Acrobat software; ability to embrace new technologies. Excellent communication, presentation, interpersonal skills, both written and spoken (English required), with an ability to inform, influence, convince, and persuade Flexibility and the ability to mentor new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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.

Keyskills :
researchcomputer skillsstandard operating proceduresapimicrosoft wordhplcvalidationamericans with disabilities actaudio masteringteam trainingquality controlchemistry