Job Description

ICON just opened a Global Clinical Study Specialist position, and I wanted to see if you know anyone that might be interested.

Must be open to hybrid office/home based in Warren NJ or Armonk NY - 3 days per week in office with the other 2 days remote.

Full time, direct hire, full benefits with salary up to $85,000 (No bonus)

2 years of related industry experience including at a Pharmaceutical or Biotechnology company: eTMF, supporting global trials, Oncology or Hematology experience.

Meeting Minutes and action items • Tracker management (list possible trackers) • Site communications • CRO communications/oversight • TMF responsibilities: IRR, EDL, uploading documents • ICF updates • Protocol Deviation Review meeting • feasibility---- Must understand the protocols, understand protocol deviation.

Global studies experience• Processes Veeva Vault / Medidata RAVE EDC / Sharepoint / ODR Operational Data Repository reports / MyQumas / AIR Tracker (Excel) / QMOD (CRC review, SSN Reporting) / Oracle / MS Teams-- experience in vendor interaction and oversight preferred

Clinical Study Specialist position

You are:

Must have a Bachelor's Degree

• Must have a minimum of 2 years industry related work experience
• Experience supporting global trials (NA, LAM, EU, APAC, India)
• Experience working in TMF, CTMS, Sharepoint,
• Excels in written and verbal communications
• Self-starter, can work independently with minimal oversight, solution-oriented
• ICF review experience
• General competency: powerpoint/excel skills, meeting minutes
• Vendor management/oversight experience a plus
• Must be open to hybrid office/home based in Warren NJ or Armonk NY

Required qualifications

• Have you completed the following level of education: Bachelor's Degree?

Ideal Answer: Yes

• Are you currently, or have you recently been, working at a Pharmaceutical, Biotechnology company or CRO as an FSP?

Ideal Answer: Yes

• Do you have 2 years of clinical trial support experience including eTMF, supporting global trials, Oncology or Hematology experience at a Pharmaceutical, Biotechnology company or CRO through FSP?

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