Sr Project Manager, Laboratory
About the role
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- Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (approximately <20%) domestic and/or international
- 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.
- 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 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.
- Working familiarity with Word, Excel, PowerPoint
- Excellent Oral and Written Communications
- Ability to Multi-Task
- Ability to remain composed and professional in stressful situations, performing effectively with shifting priorities, workload and external pressures.
- Excellent Presentation Skills
- Organizational Agility
- Ability to work with, and maintain the confidentiality of customer proprietary information.
- Mastery in following established processes and use of all laboratory PM tools (e.g. configuring laboratory databases, tracking results, ordering supplies, )
- Knowledge and familiarity with the clinical trials industry
- Ability to successfully perform job functions with little or no supervision
- Ability to effectively apply learned principles to broader situations
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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