Manager, Study Start-up and Regulatory (Italy) - LEADING CRO!
Nr ref.: /JOBS.pl
After a recent partnership with one of the top 10 global CRO's, I am looking for experienced professionals with a Regulatory affairs background to be appointed at a senior level.
The company is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world's pharmaceutical, Biotech, and medical device industries. They appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site identification and Feasibility, Site contracts, Ethics & Regulatory, and patient recruitment.
To strengthen their Ethics and Regulatory department in Italy, they are seeking an experience Manager of Study start up and Regulatory, to be based in their Saronno office. As a senior member of the 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.
Main responsibilities include managing work and teams within a specific or broad area of site start-up, such as site activation, regulatory, submissions, site contracts, or regulatory records; analyzing processes & developing strategies to increase efficiency and performing operational level planning, including efficient allocation of resources within the department. As well as participating in business development presentations such as subject matter expert in Site Start-up and Regulatory functions within the company.
To apply for this role you will need moderate experience in a clinical research organization and related contract management or site start up, experience managing staff, and a thorough knowledge of applicable regulations, drug development and clinical project management procedures.