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.
Country Study Start-Up Specialist 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.
Country Study Start-Up Specialist 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 Associates is a specialist Pharmaceutical and life science headhunting firm. For more information get in contact with Megan Field on +44 203 3854 7700 or firstname.lastname@example.org if you're looking to take a step up in your career.