Project Manager I EDS

Overview

The Project Manager, Bioanalytical Services (Flow Cytometry) serves as the primary client and project contact for assigned bioanalytical studies, overseeing the successful delivery of projects from startup through final reporting and closeout. This role is responsible for coordinating cross-functional teams, managing study timelines and deliverables, ensuring operational readiness, and providing scientific oversight for studies involving Flow Cytometry.

The Project Manager partners closely with laboratory operations, quality assurance, data management, and sponsors to ensure studies are executed in accordance with protocols, regulatory requirements, contractual obligations, and company procedures. While project management experience is preferred, candidates with strong technical expertise in Flow Cytometry and a desire to develop project leadership skills are encouraged to apply.

The Role

• Recognize, exemplify, and champion ICON's values centered around our commitment to People, Clients, and Performance.
• Serve as the primary project contact for assigned bioanalytical studies and sponsor interactions.
• Manage study timelines, deliverables, milestones, budgets, and resource planning to ensure successful project execution.
• Collaborate with laboratory operations and management to ensure appropriate staffing and resources are available to meet study timelines.
• Coordinate bioanalytical studies to ensure alignment between laboratory activities and in-life study phases.
• Monitor sample receipt, tracking, testing progress, storage, and final disposition throughout the study lifecycle.
• Review study protocols, amendments, contracts, and client requirements to ensure successful implementation and compliance.
• Prepare and maintain study-specific analytical plans and coordinate client review and approval processes.
• Provide sponsors with regular project updates, status reports, forecasts, and timely communication regarding risks, challenges, and mitigation plans.
• Facilitate communication between laboratory operations, quality assurance, data management, and sponsors to support study execution.
• Monitor project scope and identify changes requiring change orders or contract modifications.
• Track study progress against timelines and ensure agreed deliverables are completed on schedule.
• Review and approve analytical data and documentation in accordance with applicable SOPs, study requirements, and GxP regulations.
• Partner with laboratory teams to investigate unexpected results, deviations, or technical challenges and support resolution activities.
• Support preparation, review, and completion of study reports and client deliverables.
• Maintain accurate study documentation and ensure records remain audit and inspection ready.
• Ensure all project-related documentation is properly archived upon study completion.
• Contribute to process improvement initiatives and support continuous enhancement of project delivery and operational efficiency.
• Maintain awareness of current industry trends, technologies, and regulatory requirements related to bioanalytical testing.
• Travel domestically and internationally as required (approximately 1%).
• Perform additional responsibilities as assigned.

To Be Successful in the Role, You Will Need

• Bachelor's degree or higher in Life Sciences, Biology, Immunology, Biochemistry, or a related scientific discipline.
• 5+ years of experience in a bioanalytical laboratory environment.
• Demonstrated hands-on experience with Flow Cytometry is required.
• Strong understanding of regulated laboratory environments, including GLP/GCP requirements.
• Experience reviewing, analyzing, and interpreting bioanalytical data.
• Excellent communication, organizational, and stakeholder management skills.
• Strong problem-solving and analytical abilities.
• Ability to manage multiple priorities while maintaining high-quality client service.
• Proficiency with Microsoft Office applications and laboratory information management systems.

Preferred Qualifications

• Experience with Ligand Binding Assays (LBA) is desirable but not required.
• Previous project management, study management, or client-facing experience is preferred but not required.
• Experience serving as a scientific, technical, or operational lead on bioanalytical studies.
• Experience supporting biomarker, immunogenicity, cell-based assay, or other advanced bioanalytical programs.