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Job Details

Study Start-up Associate

Company: Docs Global (Continental Europe)
Location: Sesto Fiorentino (FI),Italy
Reference: Ref AS-015061
Closing Date: 28 Oct 16
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

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

Job Requirements

Bachelor Degree
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

Remuneration & other details

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!

Apply for this job: Study Start-up Associate

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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