Project Leader II

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.

Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance. * 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 1%) domestic and/or international.*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.Oversee more complex projects (e.g., method validations, endogenous biomarkers, novel methods), which may require close collaboration with Lab Managers.Assume the lead in hosting sponsor calls and insure the agenda and meeting minutes are maintained accurately. * Act as the Project Leader for high profile projects to ensure client satisfaction.Assist in the training and/or mentoring of Project Leader I.Benefits of Working in ICON: Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.