At QIAGEN, we are driven by a simple but powerful vision:
making improvements in life possible.We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams. We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.At QIAGEN, every day is an opportunity to make a real-life impact.Join us, grow with us, and together, let's shape the future of biological discovery.Position Description
This is a global role;
we are looking for candidates located within the UK, EU, USA, or Canada.The (Senior) Clinical Study Lead (CSL) serves as a key member of the project core team with the goal of significantly contributing towards the efficient launch of new or improved products.Key responsibilities:
Design, strategize, and plan (including timeline, resources, and budget) for QIAGEN-sponsored clinical studies. Lead a clinical sub-team and coordinate activities with internal and external stakeholders such as pharma partners, central labs, test sites, and provide regular status updates.Develop and execute all study-related documentation including protocols, investigator brochures, informed consent forms, contracts, and clinical study reports.Coordinate site management activities such as study startup, site preparation, compliance, and close-out procedures. Collaborate with stakeholders (Product Development, Statistics, QA, Regulations, etc.) to ensure compliance with relevant regulations, guidelines, and SOPs.Oversee the performance of study applications to ensure compliance with IVDR and other regulatory requirements. Support submission processes and address RFIs from NCAs/ECs. Assist in submitting documents to regulatory authorities, IRBs, and local agencies, and respond to their queries.Position Requirements
MSc in Life Sciences, Biomedical Engineering, or a related field;
PhD preferred or equivalent experience.Significant experience in an in vitro diagnostic devices company, ideally in a Clinical Affairs role;
experience with companion or complementary diagnostics is highly desirable.Knowledge of regulatory requirements and industry practices (e.G., FDA CFR, ICH GCP, ISO standards, IVDR, CLSI guidance, design control).Familiarity with electronic Data Capture (eDC), eTMF, Clinical Trial Management Systems (CTMS), or similar clinical operations systems.Experience in authoring clinical study documents such as protocols, investigator brochures, and informed consent documents is desirable.Willingness and ability to travel nationally and internationally up to 10%.What we offer
Bonus / CommissionLocal benefitsReferral ProgramInternal Academy (QIALearn)Hybrid work (conditional on your role)Employee Assistance Program and internal QIAGEN communitiesOur people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.QIAGEN is committed to creating an inclusive 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, veteran status, or disability.J-18808-Ljbffr
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