Study Manager - Respiratory

Updated: Yesterday Location: Morrisville, NC, United States Job ID: 25108965 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. Job Responsibilities Project Leadership and Delivery – Manage a project as a project manager overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOP’s, and regulatory requirements. Primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the contractual agreement. Lead project team to ensure quality, timelines and budget management. Accountable for the financial performance of each project; coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements and be accountable for all project deliverables. Responsible for quality and completeness of TMF for assigned projects. Accountable for maintenance of study information on a variety of databases and systems. Responsible for study management components of inspection readiness for all aspects of the study conduct; oversight for development and implementation of project plans. Plan, coordinate and present at internal and external meetings; prepare project management reports for clients and management. Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals. Develop strong relationships with current clients to generate new and/or add‑on business for the future. May participate in bid defense meetings when presented as a potential project manager. May be required to line‑manage other project management team members and clinical monitoring staff. Qualifications Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing or a comparable combination of education and experience. Experience in a clinical research organization (CRO) and relevant therapeutic area preferred; strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements. Strong organizational skills and ability to manage time and work independently. Direct therapeutic area expertise. Ability to embrace new technologies. Excellent written and spoken communication, presentation, and interpersonal skills. Ability to travel as necessary (approximately 25%). Benefits Company car or car allowance. Health benefits including Medical, Dental and Vision. Company match 401(k). Eligibility to participate in Employee Stock Purchase Plan and earn commissions/bonus based on company and individual performance. Flexible paid time off (PTO) and sick time, including compliance with applicable federal, state and municipal paid sick time requirements. EEO Statement 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. #J-18808-Ljbffr Syneos Health, Inc.