Project Leader Supervisor

• 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.
• Manage relationship with sponsor and stakeholders. May work independently of project management.
• Manage analytical studies to ensure that bioanalysis is well coordinated within the life of the study and that samples are appropriately tracked throughout the lifetime of the study and any agreed storage period. Monitor and evaluate the projects progress with respect to milestones, budgets and timelines.
• Work with laboratory management to ensure that appropriate resources are available to complete the study to timeline. Obtain all sponsor specific documents required for the analysis, ie study protocol, randomization lists, COA, demographic etc
• Prepare analysis plans suitable to the sponsors needs and obtain sponsor approval of these.
• Coordinate with analytical teams to ensure that study plans and validation plans, as appropriate are complied with.
• Work with sponsors to ensure studies are conducted in a manner compliant with the sponsors stated needs as defined by contract, and that the project delivery, reporting specifics, timelines agreed to are met. Inform DS and QC/QA of deadlines.
• Maintain records of work conducted in a timely and consistent manner, allowing real-time tracking of the deliverables, including tracking of revenue and resources associated with assigned studies. Inform stakeholder of changes to scope or timelines.
• Identify changes to scope of work and notify contracts of need for change order.
• Serve as a source of technical expertise to sponsor and other ICON employees.
• Review and approve all data in accordance with direction documents and ensure results are documented accurately, completely and compliant with GLP/GCP regulations and SOPs. Identify and provide repeat list, ISR and stability time points.
• Proactively identify possible/potential implications of unusual results. Lead an investigation 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.
• Supervise administrators, project leader assistants, project leader I and project leader II level employees.
• Submit billing details to assist the finance department with their invoice billing.
• Ensure that all documentation is appropriately archived on completion of the study.
• Check and verify laboratory notebooks and other analytical data as required.
• Author SOPs as needed. Maintain awareness of and adherence to all current SOPs.
• Work in compliance with GLP/GCP.