Project Manager I EDS
ICON
Project Manager I (Flow Cytometry)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.At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership, and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. 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.OverviewThe 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 RoleRecognize, 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 NeedBachelor'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 QualificationsExperience 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.
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