Regulatory Submissions (Study Start-up) Manager

Recruiter
Medpace
Location
Stirling
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 40 countries across the globe. We continue to steadily grow and are looking to add to our team! Our 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. RESPONSIBILITIES * Efficiently manage and successfully execute all aspects of global device trial start-up according to Sponsor specifications; * Oversee regional and/or global operational team preparing submission packages * Prepare and/or review documents for RA and EC submission packages * Review pertinent regulations to develop proactive solutions to start-up issues and challenges * Provide advice to sponsors and project teams on device regulations and strategies * Present during bid defenses, general capabilities meetings, and audits. REQUIREMENTS * Life sciences degree * More than 5 years of experience in devices clinical research. * Essential to have knowledge and experience with Device Clinical Trial Applications within Europe. * Advantage to have knowledge and experience with Pharmaceutical Clinical Trial Applications within Europe. * Strong oral and written communication skills. WHY MEDPACE? At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally. WHAT TO EXPECT NEXT We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.-1

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