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Study Start Up Associate II

Chennai
Permanent
Reference: JR067519
Description

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

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.

Summary

Provide support towards US SSU Maintenance Activities. Including but not limited to;
# Coordinating IRB Submissions & follow up for approvals
# CTMS and Tracker Updates
# Timely TMF QC and uploads

The Role

  • 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

  • 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.

  • Liaise with internal ICON and external (e.g. site personnel, IRBs etc.) stakeholders to deliver maintenance support activities during the clinical trial

What you need

  • Bachelor's degree in a life science/health related sciences, or equivalent

  • Minimum of 4 to 5 yrs of experience in IRB submissions and approvals, Ethics committee submissions for US & EU

  • Excellent communication skills

Why join us

Ongoing development is vital to us, and as a Medical Writer, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

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