Senior Project Manager, Laboratory

IRE • Raleigh, NC

2d

About The Position

Senior Project Manager, Laboratory ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Project Manager, Laboratory to join our diverse and dynamic team. As a Senior Project Manager, Laboratory at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. Senior Project Manager, Laboratory- Location: Blue Bell PA, or Raleigh NC or Farmingdale NY That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. 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 less than 20%) domestic and/or international

Requirements

• Bachelor's degree or local equivalent in science, or related field.
• 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

• 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.
• Provide training to other PMs as requested by management.

Benefits

• In addition to your competitive salary, ICON offers a range of additional benefits.
• Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Our benefits examples include:
• 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
• Number of Employees: 5,001-10,000 employees