Senior Project Manager, Laboratory

IRE • Raleigh, NC

2d

About The Position

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.

Requirements

• Solid clinical laboratory operations experience, with the ability to manage competing priorities and develop your team.
• 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.

Responsibilities

• 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.

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior