Design, plan, coordinate, and conduct clinical research studies across assigned sites.
Act as the primary contact and clinical trial expert for assigned study site personnel, delivering technical assistance and coordinating necessary training.
Perform comprehensive site assessments and qualification visits to drive informed site selection decisions.
Collaborate cross-functionally to ensure investigational sites properly obtain and maintain institutional approvals and meet all regulatory compliance needs before trial initiation.
Author and review key study site documents, including Study Monitoring Plans, informed consent forms, and case report forms.
Execute all data generation, data validation, and comprehensive site visits across all study phases, from start-up through to close-out.
Work dynamically within local, global, and virtual study teams, collaborating with R&D, Field Service, Study Management, and Biometrics to deliver top-tier solutions.

A Bachelor's degree in a scientific discipline or a related field (or an equivalent combination of education and experience).
Hands-on experience in a clinical laboratory or clinical lab study coordination is highly valued.
Typically brings professional experience, with solid conceptual and practical knowledge of clinical operations or diagnostic product development.
Good knowledge of, and strict adherence to, clinical trial and laboratory standards, including ICH-GCP guidelines, FDA Regulations, and IVDR.
Proven ability to partner across diverse regions, cultures, and time zones to cultivate an environment of belonging, inclusion, and diversity.
Exceptional verbal and written communication skills in English, allowing you to explain complex data clearly in straightforward situations.

Clinical Site Manager, Molecular Lab

Key skills