ProClinical is currently seeking a Senior SSU & Regulatory Specialist for a global CRO based in Milan, Italy. As a member of this CRO's Study Start Up team you will traverse all therapeutic areas and phases, providing your expertise at this vital period of time in the study. This expertise at this critical time has resulted in the average study start up time four weeks faster than industry standard.
- Reviewing essential document packages for site activation
- Preparation and submitting of Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required
- Reviewing Informed Consent Forms
Skills and Requirements:
- Previous experience in clinical research including submissions experience
- Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive as well as any applicable rules applicable locally.
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 Francesca D'Arpa on +44 207 440 0630 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.