Abbott Clinical Project Manager in Lake Forest, IL in Lake Forest, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
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.
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.
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, ability to travel (20-35% US and/or international), and participation in professional activities outside of normal business hours
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org