ABBOTT LABORATORIES Clinical Project Manager - Immunoassays & Clinical Chemistry Assays Salary in the United States

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 103,000 colleagues serve people in more than 160 countries.

Position Summary:

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.

Core Job Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system.　

• 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.
• Travel: up to 25% (USA only; e.g. other Abbott office locations, client hospitals and reference labs, etc.)

Accountability:

• 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.

Minimum Education:

• Bachelor’s Degree required.
• Other: Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) desirable

Minimum Experience/Training:

• 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 Qualifications:

• B.A. or B.S. in the biological sciences.
• Master’s Degree is preferred. Other: Medical Technology MT(ASCP) or equivalent, or certification as a clinical research associate (CCRA) is desirable.
• This position requires an understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, statistical, regulatory and compliance requirements of clinical research.
• Minimum of 7-8 years relevant professional experience including: Clinical Research; 3 to 5 years and Supervisory or management experience; 2 to 4 years and Laboratory (hospital, research, industrial) 3 to 5 years or Quality Assurance/Auditing; 1 to 2 years or Diagnostic Customer Contact; 1 to 2 years.
• Other: This position requires previous experience managing large or complex clinical studies; the ability to achieve goals through interaction with individuals not under their direct control; excellent oral and written communication skills, familiarity with desktop computer office software, and participation in professional activities outside of normal business hours.