Country Study Start-Up Specialist - CRO - Italy

Posted 10 November 2022
Salary Competitive
LocationItaly
Job type Full Time
DisciplineCRO & Clinical Operations
Contact NameMegan field

Job description

​​Mantell Associates have partnered with a global organization who are in search for a Country Study Start-up Specialist

Are you looking for an amazing opportunity with solid career progression?

Are you in search for a better work-life balance?

​The organisation we are partnered with are going from strength to strength, implementing a new RPM reduced monitoring structure to better the work-life balance of every employee.

Responsibilities:

  • Review and prepare local submissions, documents and perform submissions.

  • Acting as the local expert when it comes to ethics committee and regulations at a country level

  • Serves as applicant for Clinical trials/RWE and may act as main point-of-contact for the Ethics Committees and Competent Authority and the assigned RASSU Specialist to the study on the country level.

  • identifies and establishes relationship with site personnel responsible for budget proposals.

Requirements:

  • Associate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience

  • A minimum 2 years of experience in Clinical Research (pharmaceutical, site or CRO service) and experience in regulatory in Italy

  • Ability to collaborate well in a global team environment

  • Strong working knowledge of GCP, EU regulations and ICH guidelines, Drug Laws on country level

  • Excellent verbal and written communication skills

Mantell Associatesis a specialist Pharmaceutical and life science headhunting firm. For more information get in contact with Megan Field on +44 203 3854 7700 or megan.field@mantellassociates.com if you're looking to take a step up in your career.