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As a Senior Project Manager, Laboratory at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. You will oversee clinical laboratory operations workstreams, ensuring deliverables meet quality and timeline expectations.
Job Responsibility:
Ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Central Laboratories' (ICL) services, including the setup and day-to-day management of studies
Attend and represent ICL 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
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 Central 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 review clinical study specific materials. When possible, coordinate with other departments for the preparation of 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. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained and filed
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 ICO Labs system. Inform team leader about study progress. Escalate issues of potential client/site dissatisfaction to appropriate management
Proactively monitor study budget
Set the timelines for and monitor the progress of shipment requests for storage samples and verify data
Close the protocol as per ICL procedures. Includes facilitating DB Lock and coordinating with relevant internal departments
Attend and represent ICON at Sponsor Investigator Meetings, Kick-Off Meeting Bid Defenses, or Initiations
Performs additional relevant responsibilities as requested by management
Requirements:
Bachelor's degree in a relevant field such as life sciences or healthcare
Previous experience in project management within a laboratory or clinical research setting
Strong leadership skills with the ability to mentor and train junior PMs
Excellent communication and interpersonal skills, with the ability to represent the company at client meetings and internal meetings
Detail-oriented with strong organizational skills to effectively manage study documentation, timelines, and budgets
Willingness to travel as required (approximately 20%)
Minimum of 5 years of experience in a clinical laboratory, clinical trials, or customer management role in a life science related organization
Minimum of 3 years of Project Management experience in a service area serving clinical trials, such as IVRS, Clinical supply packaging and distribution, medical imaging, data management
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others