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.
Post : Study Start Up Associate I
Responsible for the review and approval of site level critical documents which are part of the Critical Document Package (CDP) for Investigational Product (IP) release in accordance with ICH/GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines and sponsor requirements.
Key Responsibilities & Duties:
• Recognize, exemplify and adhere to ICON's values which centre around our dedication 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.
• Liaise with internal ICON and external (e.g. site personnel, IRBs etc.) stakeholders to deliver maintenance support activities during the clinical trial.
• Prepare, coordinate review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trial authorizations and approvals.
• Collect critical documents for maintenance activities. Assist with finalization/approval of country and site Specific SIS/ ICFs in collaboration to the LIC team.
• Perform site contract negotiation including of budget and contract amendments, as required. Upload final documents to agreed electronic filing system (Activate, TMF, etc.) and perform updates as required to systems e.g. CTMS. Lead activities/ tasks and complete the deliverables within timelines, as needed.
Any life science , 2+ years of experience in B&C related domain (within a CRO/ Pharma)
Experience : 2+ years
Qualification : Any life science
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Reference : 058056
End Date : 30th September, 2019
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