Regulatory Submissions (Study Start-up) Manager
Medpace ·
Job SummaryOur clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based, Regulatory Submissions Manager to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace.
If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. 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; andPresent during bid defenses, general capabilities meetings, and audits.
QualificationsExtensive experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;Knowledge and experience of Clinical Trial Applications within Europe; Strong oral and written communication skills; andTeam oriented approach and strong leadership skills.
Medpace OverviewMedpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research.
We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
Why Medpace? When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven WorkWork alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellenceCollaborative CultureContribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
Leadership throughout Medpace is both accessible and approachableContinuous Growth & DevelopmentOffice based environment with on-site mentorsDefined career paths with clear advancement opportunitiesIndustry renowned onboarding and training programs designed to accelerate professional developmentOngoing training and continuous learning opportunities throughout your careerAn environment that encourages employees to influence change, contribute ideas, and grow quicklyOther Employee BenefitsCompetitive compensation programs that recognize and reward performanceComprehensive health, wellness, retirement, and PTO benefitsOffice based culture with occasional WFH that provides flexibility for eligible positions after trainingCompany-sponsored social events Please note benefits may vary based on country.
What to Expect NextA Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted. Job SummaryCategory: Site Activation & Maintenance