Gateway Recruiting, INC. Santa Clara, CA
- Expired: over a month ago. Applications are no longer accepted.
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 the 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 investigators 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:
- 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 of 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.
- Leadership experience; will be managing up to 6 direct reports
- Budgeting experience
- Global study management knowledge
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Gateway Recruiting, INC.
AddressSanta Clara, CA
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