ProClinical is seeking a Regulatory Submissions (Study Start-up) Manager for a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. This Regulatory Submissions Manager role will be a full-time, office-based role that will join the Clinical Operations team. This position plays a key role in the clinical trial management process at the CRO. 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.
- 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
- Present during bid defences, general capabilities meetings, and audits.
- 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.
- Travel: Minimal
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks] on +44 203 7520 314 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.