Project Manager I EDS

ICON plc • Lenexa, KS

9d • Onsite

About The Position

Project Manager I EDS- Lenexa, KS; Full-Time 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.

Requirements

• A suggested minimum of 3 years’ experience in a laboratory or project management role, at discretion of hiring manager.

Responsibilities

• Monitor and evaluate bioanalytical projects progress with respect to milestones, budgets and timelines.
• Manage bioanalytical studies to ensure that bioanalysis is well coordinated with in life study phases, and that samples are appropriately tracked throughout the lifetime of the study and any agreed storage period.
• Work with laboratory management to ensure that appropriate resources are available to complete the study to timeline.
• Obtain all client specific documents required for the analysis; i.e., study protocol, randomization lists, COA, demographics, etc. Review protocol and amendments to assure adherence to specifications and regulatory requirements.
• Prepare analysis plans suitable to the client’s needs, as specified by contract, and obtain client approval of these.
• Work with laboratory operations to ensure compliance to study and validation plans.
• Provide Sponsors with regular updates, forecasting and communicating study progress. Timely reporting of any significant deviations.
• Ensure that project delivery, reporting specifics, and timelines as agreed are met. Inform laboratory operations, DM and QC/QA of deadlines.
• Maintain records of work conducted in a timely and consistent manner, sufficient to allow real-time tracking of deliverables, including tracking of revenue and resources associated with assigned studies.
• Identify changes to scope of work as defined by contract and ensure that change orders are processed prior to work being executed.
• Review and approve all data in accordance with direction documents and ensure results are documented accurately, completely and compliant with GxP regulations and SOPs. Initiate investigations and event deviations as necessary.
• Proactively identify possible/potential implications of unusual results, work with laboratory staff to investigate and report findings.
• Prepare reports of the work conducted, address all QA findings and provide QA draft report in line with the terms and conditions stated in the signed contract.
• Ensure that all documentation is appropriately archived on completion of the study.
• Review and approve laboratory notebooks and other analytical data as required.
• Maintain awareness of and adherence to all current SOPs.
• Work in compliance with GLP/GCP.
• Any other duties related to maintaining the provision of the Laboratory Analytical Services.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed