Senior Project Manager, Laboratory

Senior Project Manager, Laboratory<p></p><p><span>ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</span></p><p></p><p></p><p></p><p>At ICON, it’s our people that set us apart.</p><p>As a global provider of drug development solutions, our work is serious business. But that doesn’t mean you can’t have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?</p><p>As a Snr Project Manager Laboratory, you will ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Central Laboratories services, including the setup and day-to-day management of studies.</p><p><b>The role</b></p><ul><li>Act as the sponsor's main contact person in all matters regarding our central laboratory services,</li></ul><p>following up and responding to clinical study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and the ICON internal departments.</p><ul><li>Review newly assigned protocols and Amendments. Coordinate and manage the completion of the Clinical Laboratory Worksheet (CLW) and communicate information as required to other departments within ICON Laboratories (and ICON Clinical CRO if appropriate).</li><li>Ensure that proper guidelines for communication are set at study start-up and maintained throughout a study by creating and updating the study Project Management Plan</li><li>Ensure adherence to the protocol specific monitoring plan. Maintain clinical study specific study files and ensure that all appropriate documents are properly maintained. Ensure that all necessary documents are archived at study closure.</li><li>Provide Sponsors with study management reports as required and agreed. Provide client with support on ICOLabs and iSite systems.</li><li>Proactively monitor study budget through monitoring of Protocol Tracking reports and other tools provided to assist</li><li>Regularly use the PM Dashboard to help monitor study progress and communicate to Sponsors in a timely manner if issues identified may require further investigation</li><li>Set the timelines for and monitor the progress of shipment requests for storage samples and verify data.</li><li>Attend and represent ICON at Sponsor Investigator Meetings, Kick-Off Meeting, Bid Defenses or Face to Face Governance meetings.</li><li>Serve as a leader, mentor and consultant to more junior team members in resolving issues or</li></ul><p>questions as they arise.</p><ul><li>Serve as a gateway for escalation of PM issues to PM Manager and Senior/Executive Management</li></ul><p><b>What you need</b></p><ul><li>In depth proven experience working in a clinical laboratory, clinical trials, or customer management/account management role in a life sciences related organization</li><li>Prior relevant experience successfully performing a Project Management role in a service area serving clinical trials, such as IVRS, Clinical Supplies Packaging and Distribution, Medical Imaging, Data Management, or Electronic Data Capture.</li><li>Successful management in providing technical services for multiple clinical trials, including Presentation at Investigator Meetings, Implementation of protocol amendments, Completion of Laboratory Configurations, Trial reconciliations, Participation in sponsor/regulatory audits, Bid Defenses</li><li>Bachelor's degree or local equivalent in Science, Business or related Field and/ or an alternative combination of experience, education, and training.</li></ul><p></p><p><b>What ICON can offer you:</b></p><p></p><p>Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</p><p></p><p>In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</p><p></p><p></p><p>Our benefits examples include:</p><ul><li><p>Various annual leave entitlements</p></li><li><p>A range of health insurance offerings to suit you and your family’s needs.</p></li><li><p>Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</p></li><li><p>Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.</p></li><li><p>Life assurance</p></li><li><p>Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</p></li></ul><p></p