ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: Document Management Associate/Assistant - 008035
Job Description
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a Document Management Associate you will complete Document Management activities in support of client services contracts and internal ICON business needs.
Overview of the role
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Process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs and regulations, where applicable.
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Liaise with study teams and other Document Management staff in order to fulfill job responsibilities and activities.
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Complete departmental projects as assigned in accordance with specified timelines, ICON SOPs/WPs and regulations.
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Maintain study files as per study and/or client requirements or in accordance with ICON SOPs/WPs and applicable regulations.
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Complete activities related to document receipt and processing which may include but is not limited to: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.
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Provide information necessary to complete client and/or departmental status reports as requested by the management of the Document Management department.
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Inform the Manager of training issues, project activities, quality issues and timelines as directed.
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Provide copies of study documents to ICON or client personnel as requested.
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Participate in client and/or ICON audits and document archiving activities as necessary.
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Participate in training related to fulfillment of responsibilities as required by ICON and/or the client.
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Liaise with Clients, as appropriate, on project issues when directed by the Manager.
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Handle special projects or duties as requested by the Manager.
Candidate Profile
Must have TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents. Ability to successfully liaise with study project teams, staff, clients and management, as necessary. Good oral and written communication skills and interpersonal skills.
Competent computer skills.
Additional Information:
Location: Chennai
Organization: Medical & Safety Srvs
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacovigilance, CR
End Date: 20th Feb, 2014
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