Study Manager - Immunology

Role Overview Study Manager – Immunology. Responsible for planning, directing, creating, and communicating clinical study timelines and deliverables, ensuring compliance with GCP, SOP, and regulatory requirements, and maintaining the financial performance of projects. Job Responsibilities Lead project as a project manager overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOPs, and regulatory requirements. Act as the primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout in accordance with contractual agreements. Lead the 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, and account for all project deliverables. Responsible for the quality and completeness of the Trial Master File for assigned projects. Maintain study information on a variety of databases and systems. Responsible for study management components of inspection readiness for all aspects of study conduct. Oversee the development and implementation of project plans. Plan, coordinate, and present at internal and external meetings, preparing project management reports for clients and management. Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals. Build strong relationships with current clients to generate new and/or add‑on business for the future. Participate in bid defense meetings where presented as 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 equivalent 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. Strong ability to manage time and work independently. Direct therapeutic area expertise. Ability to embrace new technologies. Excellent communication, presentation, interpersonal, written, and spoken skills. Ability to travel as necessary (approximately 25%). Benefits Benefits may include a company car or car allowance, medical, dental, and vision coverage, company match 401(k), eligibility to participate in an Employee Stock Purchase Plan, eligibility to earn commissions or bonuses based on company and individual performance, and flexible paid time off (PTO) and sick time. Eligibility for paid sick time may vary depending on location. The company complies with all applicable federal, state, and municipal paid sick time requirements. EEO Statement All tasks, duties, and responsibilities are not exhaustive. The Company may assign additional tasks or duties at its discretion. The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate, and ensuring equal employment opportunity in accordance with the EU Equality Directive and applicable legislation. No discrimination will occur on the basis of race, color, religion, sex, national origin, age, disability, or any other protected status. #J-18808-Ljbffr Syneos Health, Inc.