Clinical Trial Project Manager

7 days ago


Alameda, California, United States Abbott Full time

Overview of Abbott

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 114,000 colleagues serve people in more than 160 countries.

The base pay for this position is $55,200.00-$110,400.00, commensurate with location and experience. In addition to a competitive salary, we offer a comprehensive benefits package, including free medical coverage for employees via our Health Investment Plan (HIP) PPO, an excellent retirement savings plan, tuition reimbursement, and education benefits.

About the Role

The CRA II will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards. The incumbent may be asked to perform other function-related activities as reasonably required by business needs.

Responsibilities:

  • Conduct single or multi-center medical device clinical studies.
  • Perform study site visits, generate monitoring trip reports, and track resolution of action items.
  • Participate in study start-up activities.
  • Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements.
  • Proactively and effectively communicate the status of clinical studies to management.
  • Evaluate, select and train new study investigators.
  • Maintain and audit Trial Master File to ensure inspection readiness.
  • Review of clinical data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed.

Requirements:

  • Bachelor's degree in life sciences or equivalent with minimum 5 years of CRA or CRC experience, or combination of appropriate education and experience.
  • Must have 3+ years of relevant experience in site monitoring, clinical project management, clinical trial practices and regulations.

Benefits:

We provide a comprehensive benefits package, including free medical coverage for employees via our Health Investment Plan (HIP) PPO, an excellent retirement savings plan, tuition reimbursement, and education benefits.

About Us

Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. Learn more about our health and wellness benefits at www.abbottbenefits.com.



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