Clinical Study Lead – In Vitro Diagnostics
Hybrid · Manchester, England, United Kingdom
Job Summary
Clinical Study Lead (CSL) for In Vitro Diagnostics at QIAGEN. Lead global clinical performance studies supporting development and regulatory approval of diagnostic solutions in Oncology and Biopharma Companion Diagnostics. Design and execute study strategy and timelines; produce protocols, investigator brochures, informed consent forms, contracts, and study reports; manage site selection, start-up, conduct, and close-out; coordinate with CTAs, CRAs, and cross-functional teams to ensure regulatory deliverables. Ensure compliance with FDA CFR, ICH GCP, IVDR, ISO standards, and global regulatory requirements; support audits. Travel up to 20% for global study activities. Advanced degree required with PhD or equivalent preferred; strong experience in IVD, oncology/companion diagnostics, and authoring clinical documents. Hybrid work options available.
Required Qualifications
- Advanced degree in Life Sciences, Molecular Biology, Biomedical Engineering, or related field; PhD or equivalent experience preferred
- Proven experience in an in vitro diagnostics (IVD) organization, ideally in Clinical Affairs or Clinical Operations
- Experience in oncology and/or companion diagnostics is highly desirable
- Demonstrated experience authoring clinical study documents such as protocols, investigator brochures, and informed consent forms
- Strong working knowledge of regulatory and industry standards, including FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, and CLSI guidance
- Familiarity with clinical operations systems such as eDC, eTMF and CTMS
- Ability and willingness to travel internationally up to 20%
- Role involves leading design, strategy, planning, documentation, site management, and regulatory submissions
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