Associate Study Start-Up Manager - Dallas

Associate Study Start-Up Manager - Dallas Job Locations United States-TX-Irving (Dallas) Category Clinical Operations 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 approximately 3,500 people across almost 40 countries. Job Summary Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Regulatory Submissions/Study Start-Up Manager to join our Clinical Operations team in our Dallas office. This position plays a key role in the clinical trial management process at Medpace.

Incenvites can include: competitive bonus program, sign-on/relocation bonus, and equity awards. Responsibilities Efficiently manage and successfully execute all aspects of global start-up; 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 issues and challenges; and Present during bid defenses, general capabilities meetings, and audits Qualifications Bachelor's degree required, advanced degree in Life Sciences preferred 3 - 5 years of experience in clinical research, preferably in a Senior/Lead role at a CRO in Study Start-Up Project management experience Strong oral and written communication skills.

Travel: Minimal Why Medpace? When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

Awards: Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer Recognized by Forbes as one of America's Best Mid-size Companies in 2021 Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

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