Project Manager II, Laboratory

Project Manager II, Laboratory

ICON

Dublin, Ireland

The role:

• Act as the sponsor's main contact person in all matters regarding our central laboratory services, following up and responding to clinical study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and the ICON Site Services Department.
• Review newly assigned protocols and Amendments. Coordinate and manage the completion of the Clinical Laboratory Worksheet (CLW) and communicate information as required to other departments within ICON Laboratories (and ICON Clinical CRO if appropriate).
• Enter protocol parameter information into PACS//ICOLIMS and other systems for new and/or amended protocols. Prepare and QC clinical study specific materials.
• Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study specific Communication and Escalation Plan. Ensure adherence to the protocol specific monitoring plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained. Ensure that all necessary documents are archived at study closure.
• Provide Sponsors with study management reports. Provide client with support on ICOLabs system. Inform team leader about study progress.
• Proactively monitor study budget.
• Set the timelines for and monitor the progress of shipment requests for storage samples and verify data.
• Attend and represent ICON at Sponsor Investigator Meetings, Kick-Off Meeting, Bid Defenses or Initiations.
• Develop new tools, train new employees.
• Performs additional relevant responsibilities as requested by management.

What you need:

• Bachelor's degree or local equivalent in Science, Business or related Field.
• Minimum of 2 years of experience working in a clinical laboratory, clinical trials, or customer management/account management role in a life science related organization.
• Minimum of 2 years of Project Management experience in a service area serving clinical trials, such as IVRS, Clinical Supplies Packaging and Distribution, Medical Imaging, Data Management, or Electronic Data Capture.