Country Approval Specialist job in Berlin

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Clinical Research Associate (CRA)

Location: Germany

This vacancy has now expired. Please see similar roles below...

Our client is a leading global contract research organisation providing comprehensive, integrated drug development, laboratory and lifecycle management services. Their clients and partners include pharmaceutical, biotechnology, medical device, academic and government organisations. With offices in 47 countries and approximately 20,000 professionals worldwide, our client applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.

The Country Approval Specialist will be responsible for obtaining Ethics and Regulatory approvals to conduct clinical studies and to ensure the activation of the sites in clinical studies.

Job Responsibilities:

Prepare, review and coordinate local ethics and regulatory submissions in alignment with global submission strategy;
Act as a key contact for the study team, on a country level, for the start-up related activities and provide oversight for projects;
Prepare and collect the documentation required for site's initiation in a clinical study, in collaboration with the Clinical Research Associate;
Provide local regulatory strategy and advice for the conduct of clinical trials;

Skills and Requirements:

Regulatory and submission experience or CRA experience in clinical studies
Good knowledge of all applicable national regulatory requirements.
Excellent English skills and an obtained life-science degree

To Apply:

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 Julia Tegelmann on 0203 854 1052 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.

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