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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
Vacancy expired!