ICON Clinical Research Sr Project Manager, Laboratory in Oyster Bay, New York
At ICON, it's our people that set us apart.The Project Manager, Labs will ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Laboratory Services (ILS), including the setup and day-to-day management of studies, attend and represent ILS at Client meetings, manage studies in accordance with Good Clinical Practice, provide Clients with regular study updates and communicate study progress to Clients and PM Leadership in a responsible and professional manner.
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 5 years of experience working in a clinical laboratory , clinical trials, or customer management/account management role in a life sciences related organization
Minimum of 1 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.
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?
Working familiarity with Word, Excel, PowerPoint
ICON Clinical Research
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