Country Start-up Specialist

Proclinical is working with an international CRO that is seeking a Country Start-up Specialist to be based in Warsaw on a permanent basis. The Country Approval Specialist will be responsible for obtaining Ethics and Regulatory approvals to conduct clinical studies in Poland and to ensure the activation of the sites in clinical studies.

Job Responsibilties:

• 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:

• Ideally candidates will have regulatory and submission experience or CRA experience in clinical studies and good knowledge of all applicable national regulatory requirements.
• Excellent English skills and ability to work in a team environment and independently with minimum supervision

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 Theodora Savlovschi-Wicks on +44 203 7520 314 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.