Study Start-Up Project Manager - Cell and Gene Based Therapy

Study Start-Up Project Manager - Cell and Gene Based Therapy Job Locations United States-OH-Cincinnati | United States-CO-Denver | United States-TX-Irving (Dallas) Category Site Activation & Maintenance Job Summary Do you enjoy working in a fast-paced environment where you are empowered to make strategic decisions and contribute to a growing and profitable company? Join us at Medpace! Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Global Study Start-Up Project Manager to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace. Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards. Location: Position can be office based in Cincinnati, Dallas or Denver. Responsibilities Efficiently manage successful execution of global start-up, maintenance, and close-out; Effectively lead others in a matrix environment; Perform quality checks on submission documents and site essential documents; Prepare and approve informed consent forms; Serve as a Sponsor point of contact for start-up and regulatory submissions items; Review pertinent regulations to develop proactive solutions to start-up challenges; Prepare new business proposals and present during bid defenses, general capabilities meetings, and audits; and Contribute to the growth and development of departmental staff, processes, and systems. Qualifications Bachelor's degree required, advanced degree in Life Sciences preferred 5+ years of experience in clinical research, preferably in a Senior/Lead role at a CRO in Study Start-Up Experience in the use of cell- and gene-based therapy for clinical trials Project management experience and demonstrated role in developing others Strong oral and written communication skills required Travel: Minimal Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks Cincinnati Campus Overview Hybrid work-from-home options (dependent upon position and level) Competitive PTO packages, starting at 20+ days Competitive compensation and benefits package Flexible work schedule Company-sponsored employee appreciation events Employee health and wellness initiatives Community involvement with local nonprofit organizations Discounts on local sports games, fitness gyms and attractions Modern, ecofriendly campus with an on-site fitness center Structured career paths with opportunities for professional growth Discounted tuition for UC online programs Awards Named a Top Workplace in 2024 by The Cincinnati Enquirer Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized