Study Start-Up Project Manager - Rare Disease

Study Start-Up Project Manager - Rare Disease

Job LocationsUnited States-OH-Cincinnati | United States-TX-Irving (Dallas) |

United States-CO-DenverCategory

Site Activation & Maintenance

Job SummaryDo you enjoy working in a fast-paced environment where you are empowered to

make strategic decisions and contribute to a growing and profitable company?

Are you tired of voicing ideas that go unheard? Join us at Medpace! Our

clinical operations activities are growing rapidly, and we are currently

seeking a full-time, Senior Global Study Start-Up 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.ResponsibilitiesEfficiently 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.QualificationsBachelor'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 area of rare diseases for clinical trials, e.g.,

Duchenne Muscular Dystrophy, Epilepsy, Cystic Fibrosis, Amyotrophic

Lateral Sclerosis (Lou Gehrig's), etc.

Project management experience and demonstrated role in developing others

Strong oral and written communication skills required

Travel: MinimalMedpace OverviewMedpace 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

AwardsNamed 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 with CRO Leadership Awards from Life Science Leader

magazine based on expertise, quality, capabilities, rel ability, and

compatibilityWhat to Expect Next

A Medpace team member will review your qualifications and, if interested,

you will be contacted with details for next steps.EO/AA Employer M/F/Disability/Vets