Company: Docs Global (Continental Europe)
Location: Sesto Fiorentino (FI),Italy
Reference: Ref AS-015061
Closing Date: 28 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
This is a great opportunity for an experienced SSU Associate to join an exciting and challenging work environment!
Roles & Responsibilities of the position
Responsible for the independent preparation, review and approval of country submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards.
Responsible for the independent preparation, review and approval of site level critical documents for investigational Product (IP) release in accordance with regulatory/sponsor requirements - within specific timelines and quality standards.
Develop and finalize Master and Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs).
Prepare and finalize Master and Country Specific EU Clinical Trial Application Forms and corresponding data files (xml file).
Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at kick-off, Investigator or study team meetings.
Perform feasibility, site identification, site contract negotiation and other study start up activities as assigned
At least 3 years Clinical Research experience
Experience and or understanding of clinical study start up requirements and activities
Ability to liaise with the Study Start Up Lead, colleagues from other departments and client
Good organizational skills
Customer service and solution focused
Excellent written and spoken English
Other than working with a great team of smart and energetic people, our client also offers a very competitive salary and excellent benefits package.
Permanent contract, full time and client office based in Tuscany!
2 Globeside, Globeside Business Park
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