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. We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.
Post : Study Start Up Associate I
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Perform high quality CDP reviews according to the process defined in SOP SST004 titled “Critical Documents Collection, Critical Document Package (CDP) Approval and IP Release.
• Provide SSU Lead/designee with CDP Requirement Sheet to discuss with the Sponsor.
• Update CDP Requirement Sheet during the start-up phase of studies in consultation with the SSU Lead/designee.
• Customize final Critical Document Package/IP Release Checklist and Global CDP Review Worksheet including any Sponsor, Country and Study Specific requirements.
• Complete CDP reviews within defined and agreed timelines of receipt by the CDP Review Team/designee.
• Complete review of CDP documents alongside the supporting Critical Document Package/IP release Checklist to confirm all the CDP documents are complete, consistent, current and in accordance with ICH/GCP and all applicable regulations, laws, and other guidelines and ethical standards.
• Return to CDP Submitter any documents identified as incomplete, not current or inconsistent. x Sign and date the “Approved By” section of the Critical Document Package/IP Release Checklist to confirm approval of CDPs which are complete, consistent, current and in accordance with ICH/GCP and all applicable regulations, laws and other guidelines and ethical standards. X
• Enter details of CDP review into the CDP Approval Tracker at completion of each review.
• Upload approved CDPs to agreed electronic filing system.
2 to 3 years pf experience in ICH/GCP
Deep knowledge in Documentation
Academic or Trade qualifications : Any life science
Qualification : Any life science
Experience : 2-3 years
Location : Trivandrum , Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 10th October, 2018
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