Overview
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. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
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.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
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 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.
Position Requirements
- Master’s degree in Life Sciences, Molecular Biology, Biomedical Engineering or similar. PhD or equivalent experience highly desirable.
- Significant employment experience within an in vitro diagnostic devices company, ideally in a Clinical Affairs/ Operations related role; other devices or pharmaceutical experience will be considered. Experience within oncology and/or molecular companion diagnostics would be highly desirable.
- Working knowledge of regulatory requirements and industry working practices e.g. FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, CLSI guidance, design control
- Understanding of electronic Data Capture (eDC), eTMF and Clinical Trial Management System (CTMS) or similar clinical operations systems
- Experience of authoring clinical study documents e.g. Protocols, Investigator Brochure, Informed Consent Documents is desirable
- Willingness and availability to travel nationally and internationally as required: up to 20%
What we offer
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.
