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ICON PLC Study Start Up Associate For Life Sciences, Apply Online
ICON PLC Study Start Up Associate For Life Sciences, Apply Online. BSc Life Sciences Jobs. Interested and eligible applicants can check out all of the details on the same below
Name of the Post – Study Start Up Associate I / II
Location(s) – Bangalore Urban,Chennai,Thiruvananthapuram
Type – Permanent
Reference – JR071836
The Role –
As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
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Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
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Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager Central Services or Designee.
This is an exciting opportunity to work within a fast paced environment for a leading global provider of
outsourced development services to the pharmaceutical, biotechnology and medical device industries.
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Responsible for the preparation and submission of US IRB submission packages (to US sites and IRBs) in accordance with ICH, GCP and all applicable regulations within specific timelines and quality standards.
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Coordinate creation and review of Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs).
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Coordinate translation of ICDs & Patient materials with vendors
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Responsible for the Country-Site specific TMF QC, CTMS updates within specific timelines and quality standards.
What you need
Experience in
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IRB/ Ethics Committee submission experience (CRO end) India or Global.
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TMF QC.
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On-site Monitoring
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Bachelors degree in life sciences.
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SSU experience is desirable but not mandatory.
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Experience in a clinical research environment with an understanding of Essential Documents and related review expectations (Mandatory).
APPLY ONLINE
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