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Medpace | Regulatory Submissions (Study Start-Up) Manager

Details of the offer

We are currently seeking a full-time Study Start Up Submissions Manager to join our Clinical Operations team in Melbourne, Australia.
ResponsibilitiesEfficiently 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;Review pertinent regulations to develop proactive solutions to start-up issues and challenges;Present during bid defenses, general capabilities meetings, and audits.QualificationsMore than 5 years of experience in clinical research, preferably with a CRO.
Experience may include CRA or project management experience;Regional experience will be highly advantageous;Strong oral and written communication skills.Travel: Minimal Medpace 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.
Medpace Perks Flexible work environmentCompetitive compensation and benefits packageCompetitive PTO packagesStructured career paths with opportunities for professional growthCompany-sponsored employee appreciation eventsEmployee health and wellness initiativesAwards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, 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
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Nominal Salary: To be agreed

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