Study Manager - Oncology

Updated: Yesterday Location: Morrisville, NC, United States Job ID: 25108969 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, ensuring compliance with GCP, relevant SOPs, and regulatory requirements. Primary liaison between the Company and the Customer, ensuring timely study launch, conduct, and closeout according to contractual agreements. Lead project team to ensure quality, timelines and budget management. Accountable for the financial performance of each project, coordinating activities and deliverables of all study conduct partners and proactively identifying and managing issues. Ensure studies are conducted in compliance with GCP, relevant SOPs and regulatory requirements; accountable for all project deliverables. Responsible for quality and completeness of TMF for assigned projects. Maintain study information on a variety of databases and systems. Oversee inspection readiness components and develop and implement 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. Participate in bid defense meetings as a potential project manager. Line‑manage other project management team members and clinical monitoring staff as required. Qualifications Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or equivalent combination of education and experience. Experience with a clinical research organization (CRO) and relevant therapeutic area experience preferred; strong knowledge of GCP/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 communication, presentation, interpersonal skills, both written and spoken. Ability to travel as necessary (approximately 25%). EEO Statement Syneos Health is an equal opportunity employer. Our hiring decisions are made without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic. We are committed to compliance with the Americans with Disabilities Act and other applicable laws. #J-18808-Ljbffr Syneos Health, Inc.