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Project Manager II, Laboratory
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Project Manager II, Laboratory
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The Project Manager 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, represent Project Management at internal interdepartmental meetings or interdivisional meetings within ICON, help train more junior PMs, act in an advisory role to those less experienced on the team, and work to enhance team tools and practices by actively recommending suggestions for improvements in efficiency, serve as the tactical site supervisor for project manager in the absence of a Team Lead for work related and administrative tasks and take on additional responsibilities to enhance the overall PM Team tools and Practices, as defined by Management.
- 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.
