Project Manager II, Laboratory- Farmingdale NY- Blue Bell PA- hybrid
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.
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.
- Working familiarity with Word, Excel, PowerPoint
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Top Skills
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
