.At the heart of QIAGEN's business is a vision to make improvements in life possible.We are on an exciting mission to make a real difference in science and healthcare. Our most valuable asset are our employees – more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.Join us. At QIAGEN, you make a difference every day.Position Description The Clinical Study Lead (CSL) serves as a key member of the project core team with the goal to significantly contribute towards efficient launch of new or improved products. This role will focus on Oncology and Biopharma Companion Diagnostics product areas.Key responsibilities:Study design, strategy, planning (timeline, required resources and budget) for QIAGEN sponsored clinical studies.Coordinating clinical activities with stakeholders internally and externally and providing regular status reports. This role requires close collaboration and coordination of activities with pharma partners and test labs for conducting companion diagnostic clinical performance studies.Development and execution of all study associated documentation including protocols, investigator brochure, informed consent, contracts, and reports, in compliance with relevant regulations, guidelines and SOPs.Manage and track clinical studies, ensuring study completion in a timely manner within budget, escalating potential issues, setting up and coordinating internal and external communications and meetings for correction, troubleshooting, and prevention planning.Identify, enlist and choose sites, and coordinate site management activities including ensuring study site preparation, equipment, and training are compliant to the clinical protocol and organization's SOPs.Coordinate, supervise and train internal and external teams as required. Arrange and oversee site visits. Accountable for managing site auditing or QC visits where necessary to address or improve quality. Support during audits, e.G., BIMO, Pharma partner, FDA.Oversight of regulatory requirements for conducting clinical performance studies in the appropriate geographies (e.G., IVDR requirements for EU/EEA, FDA requirements for USA etc). Liaise with internal and external stakeholders for regulatory deliverables.Accountable for study close out procedures on study binders, datasets and study supplies working with CTAs, CRAs and Data/Statistics stakeholders for close-out documents and reviews.Author clinical study reports and study related submission documents to regulatory authorities, IRBs and local agencies in line with their requirements and respond to queries
