Project Manager, Laboratory - Farmingdale, NY - seeking Research/Study Coordinators or candidates with direct Central Labs exper
About the role
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You will act as the Sponsor’s main contact person in all matters regarding ICON’s 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.
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You will 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. 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.
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You will 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 the ICON Clinical Division if appropriate.
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Enter protocol parameter information into PACS/ICOLIMS for new and or amended protocols, prepare and QC clinical study specific materials and when possible, coordinate with other departments for the preparation of study specific materials.
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Proactively monitor study budget, set the timelines for and monitor the progress of shipment requests for storage samples and verify data.
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Monitor study progress throughout the study, using ICON tools and communicate pertinent information to clients/sponsors. Provide Sponsors with study management reports. Provide client with support on ICOLabs system. Inform team leader about study progress. Escalate issues of potential client/site dissatisfaction to appropriate management.
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Close the protocol as per ILS procedures this includes facilitating Database Lock and coordinating with relevant internal departments.
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You must be available to travel at least 20% of the time and attend and represent ICON at Sponsor Investigator Meetings, Kick-Off Meeting or Initiations.
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You will possess a minimum of 2 years work experience, with one or more years of experience working in a clinical laboratory, clinical trials, project management, customer management or account management role and hold a BS or BA in a Life Science or related field.
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You will have working knowledge of MS Word, Excel and PowerPoint and possess the ability to multitask, remain composed and even-keeled in stressful situations, and perform effectively in spite of shifting priorities, workload and external pressures.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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