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The clinical project manager (CPM) 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. 4.
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.
Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates.
Early identification of unsatisfactory results,operations,or specific problems allows immediate action to be taken by appropriate groups.
Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project.
Accountable for project scope and scheduled completion date.
Works under general management direction.
Participates in professional activities in the US and/or Internationally.
Responsible for mentoring direct reports and their career development.
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.
Medical & Scientific Affairs
United States > Santa Clara : 4551 Great America Parkway
Yes, 20 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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