Regulatory Submissions Manager
Full-time or Part-time: 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, USA 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 European activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submission to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. 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.
DESCRIPTION OF JOB DUTIES
- Efficiently manage and successfully execute all aspects of global start-up according to Sponsor specifications;
- 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; and
- Present during bid defenses, general capabilities meetings, and audits.
- Line manage the regulatory submissions team.
- More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
- Knowledge and experience with Clinical Trial Applications within Europe; and
- Strong oral and written communication skills.
- Fluency in English and local language.
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.
Please apply online at Link megjelenítése.