Qualifications
Qualifications:- Proven experience in clinical operations and site management, preferably in a leadership role.- Strong understanding of clinical trial processes, regulatory requirements, and GCP.- Exceptional leadership and mentoring skills, with the ability to inspire and guide teams.- Excellent communication and interpersonal abilities, capable of collaborating with cross-functional teams.- Analytical mindset with strong problem-solving skills.- Master’s degree in Life Sciences, Clinical Research, or a related field is preferred.
About the job
About Karius
Karius is a pioneering life science company specializing in clinical metagenomics, dedicated to enhancing patient care through advanced microbial insights. We strive to push the boundaries of diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. By leveraging genomics and artificial intelligence, we aim to revolutionize the diagnostic landscape for infectious diseases. Our innovative approach allows us to detect microbial cell-free DNA in the bloodstream, enabling physicians to make swift and informed treatment decisions.
Position Overview
As the Senior Manager of Clinical Site Operations, you will lead and mentor a team of Clinical Research Associates (CRAs), serving as the site-level lead for designated protocols. You will be accountable for all aspects of site strategy, selection, activation, performance, and close-out. This role entails developing and implementing comprehensive site management plans while ensuring compliance with clinical trial protocols and Good Clinical Practice (GCP) regulatory standards. You will also ensure high standards in monitoring and data integrity throughout the study. Responsibilities include CRA training, performance evaluations, proactive problem-solving, and collaborating closely with the cross-functional clinical study team to meet project milestones.
Why Join Karius?
At Karius, we are on a mission to eradicate infectious diseases through groundbreaking advancements in genomic sequencing and machine learning. Our platform provides unparalleled insights into the microbial landscape, empowering clinicians with the ability to identify over a thousand pathogens directly from blood samples. This capability is instrumental in accelerating the development of therapeutic solutions. The innovative products Karius offers are among the most advanced in the field, designed to help physicians deliver superior care to patients who have previously been inadequately treated. Joining our team means directly contributing to transformative work that has a significant impact on patient lives at scale.
Reporting To: Director of Clinical Operations
About Karius
Karius is at the forefront of clinical metagenomics, committed to transforming the landscape of infectious disease diagnostics. Our innovative genomic solutions provide healthcare professionals with advanced tools to make informed treatment decisions swiftly, significantly enhancing patient outcomes.