Company: Docs Global (Continental Europe)
Reference: Ref AS-019774
Closing Date: 06 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
A fantastic opportunity for an experienced clinical research professional that is ready to take on a new challenge, further develop their career and enjoy working culture in our international offices in Milan.
Roles & Responsibilities of the position
The CTA is responsible for creating site folders, collating, preparing and maintaining SIP documents, updating systems.
Liase with clinical sites to collect, review and track feasibility questionnaires.
Co -ordinates entry and maintain local data into study management systems (eClinical, CDSS, etc) including setting up new studies in eClinical.
Ensure collection, review, track and provision of appropriate clinical documents to support regulatory submission to IEC.
Track and maintain adequate study related supplies in the office and facilitate their distribution to sites, including preparing and distribution Study Files Binders, study drugs and Site Initiation presentations/materials.
Organize and participate in Investigators meetings and monitor workshops as required within budget guidelines.
Provide support to responding to local audits and inspections.
Complete tracking documentation as applicable including but not limited to spreadsheet, study and contact tracker.
Orders, processes and tracks Case Report Forms (CRF) and follows up on query resolution if required to do so.
Manage local distribution of Investigator Brochure.
Provide administrative support such as word processing, photocopying, faxing, filing, managing correspondence, presentations preparation.
Set-up/maintain courier accounts and organize shipments (including but no limited to frozen samples) as required.
Experience in regulatory submissions
Work experience in life sciences, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Clinical trial process & Administration experience
Work involving data entry into systems/databases and/or business support role
Attention to details
Time management & Prioritization
Language Skill: English
Good working knowledge of common software packages
We offer a very competitive salary package and a great work environment!
This is a full time and office based role in Milan city! Starting with a temporary contract - can be extended
For an immediate consideration please send your most recent resume to email@example.com
DOCS has grown to become the premier resourcing provider of global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997 we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are: Our People, Excellence, Accountability, and Integrity.
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2 Globeside, Globeside Business Park
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