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Clinical Trial Manager
Ref No.: 18-00658
Location: Irvine, California
Position Type:Contract
Start Date / End Date: 06/11/2018 to 06/14/2019
CLINICAL TRIAL MANAGER
IRVINE, CA


Project Description:
The Sr. ACTM will support CTM/OSL in ensuring the assigned clinical study(ies) are run to time and budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Client policies and procedures.

The incumbent will assist CTM/OSL with:
  • Regional study feasibility when necessary.
  • Tracking of site training, certification(s), delivery of ancillary supplies, etc., necessary for site activation.
  • Development of study-specific documents when necessary.
  • Regional vendor management: manage vendor issues, coordinate contract amendments, create monthly vendor accruals, process and track monthly invoices, provide quarterly budget forecast assumptions.
  • Periodic review of protocol deviations.
  • Database lock activities (interim or final lock).
  • Regional study drug management: track shipping or storage site temperature excursions and coordinate new shipment requests if necessary.
  • Regional trial master file management: ensure all documents are filed in the TMF appropriately during periodic reviews and at database lock.
  • Regional enrollment management: site activation and enrollment tracking for monthly reporting.

Required Skills:
  • B.A/B.S. in science or health-related field.
  • Four (4) years clinical research experience or related experience.
  • Monitoring experience is preferred.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00658
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE