Abbott is a global healthcare leader that helps people live more fully at all stages of life.
Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
Our 109,000 colleagues serve people in more than 160 countries.
ABOUT ABBOTT HEMATOLOGY The key to successful treatment and full recovery is often fast, accurate diagnosis.
Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our location in Santa Clara, CA currently has an opportunity for a Clinical Manager, In-Vitro Diagnostics/Med Devices.
WHAT YOU’LL DO The Clinical Manager designs, implements, and monitors clinical studies of new and modified in vitro diagnostic products.
Ensures that the clinical studies are designed to validate the products’ intended use and meet regulatory requirements.
Ensures clinical studies are conducted in compliance with Good Clinical Practice (GCP).
Prepares clinical data reviews and participates in the preparation of regulatory submissions.
Manages large projects, more complex projects, and/or several smaller related projects.
Supervise clinical research associates (CRA) and other employees in the completion of tasks and projects, train and mentor new employees, and serve as a resource for newly hired CRAs.
Maintain a basic understanding of the principles of the assay and/or instrument.
Remain current with regulatory requirements via professional and educational opportunities.
Prepare and/or approve design validation plans, clinical protocols, clinical brochures, case report forms, sample consent forms, statistical plans, and other required documents for clinical studies.
Identify and qualify clinical investigators and clinical sites, proposes and negotiates budgets for clinical studies, initiates and track payments to sites and manage expenses within study budget.
Manage or coordinate all aspects of the clinical monitoring process in compliance with GCP guidelines and regulations including review of all required essential documents necessary for study initiation and ensure audit ready study files throughout the duration of the study.
Conduct site visits to provide training for investigator and staff, determine protocol and regulatory compliance and prepare required documentation ensuring data reported is accurate, complete and verifiable.
Maintain and document professional communication with the clinical site, cross functional project team, and management throughout the duration of the study.
Conduct data reviews, prepare data summaries, create the clinical sections of regulatory submissions, strategize and/or coordinate responses to regulatory agencies’ questions regarding the clinical study.
EDUCATION AND EXPERIENCE YOU’LL BRING Required Bachelor degree required.
Other: Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) desirable Minimum of 6 years clinical research related experience, of which at least 3 years’ experience with clinical studies conducted per GCP with direct clinical site monitoring and/or clinical site management experience functioning in a lead capacity with mentoring, supervisory or demonstrated leadership role.
Preferred Leadership experience; will be managing up to 6 direct reports Budgeting experience Global study management knowledge WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.
We offer: Training and career development , with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
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