Company: Docs Global (Continental Europe)
Reference: Ref AS-020173
Closing Date: 24 Jan 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
We are looking for talented and motivated candidates to join the team and take part in this dynamic project within an internationational Biotech Company.
Roles & Responsibilities of the position
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
A minimum of experience in regulatory submissions
Work experience in life sciences or medically related field, 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
At this stage we offer a temporary contract, with possibility to be extended - Office Based in Milan – Part Time (20h per week).
For an immediate consideration please send your most recent resume directly 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, Integrity, Openness.
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2 Globeside, Globeside Business Park
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