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Clinical Data Manager - APOC ( Princeton, NJ)

Company: Abbott Laboratories
Location: Princeton
Posted on: June 10, 2021

Job Description:

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 109,000 colleagues serve people in more than 160 countries.

Clinical Data Laboratory Review Specialist (Princeton, NJ) - Abbot Point of Care (APOC)

Abbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry's most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance.

Our Princeton, NJ division has an opportunity for a Clinical Data Laboratory Review Specialist, in this role you will Support of all data management activities including start-up, maintenance, and completion activities.

Responsible for ensuring clinical data is collected, handled and validated according to applicable regulations in order to deliver a high-quality database for statistical analysis.


  • Design and maintain electronic clinical research management databases
  • Maintenance of data management documentation and archiving clinical trial data and study documentation
  • Design of case report forms and database validation checks based on an understanding of the therapeutic area of interest
  • Validation of electronically captured data, querying both missing data and data points failing range checks and/or logical checks
  • Design and provision of resource materials (including source document verification reports and query status reports) to onsite monitors to assist with their onsite activities
  • Training of sites and supporting study team members on data management activities at investigator meetings
  • Ensure compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of junior data management staff, and follow-up of corrective actions
  • Ability to initiate, plan and manage projects
  • Strong decision-making skills and ability to prioritize.
  • Ability to form and develop interpersonal, professional relationships; display socially and
  • professionally appropriate behavior



  • Bachelor's Degree in Health, Clinical, or Biological Sciences.
  • 6 years of related work experience with a solid understanding of Clinical Electronic Data Capture (EDC), Clinical Trial Management
  • Systems (CTMS) and Clinical Research Data Management or equivalent
  • Excellent Communications skills, both oral and written
  • International Harmonized /Committee Good Clinical Practices, IHC/GCP
  • Implementation of FDA Title 21 CFR Part 11 Compliant Data Systems
  • Implementation of Electronic Data Capture for Clinical Studies
  • Implementation of Clinical Trial Management Systems for Clinical Studies
  • Knowledge of project management tools and techniques
  • Broad knowledge and application of business concepts, procedures and practices


  • Medical Technology, Clinical Laboratory and/or In-Vitro Diagnostics experience preferred

Ability to travel approximately 5% (US and Canada)


At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:

Keywords: Abbott Laboratories, Trenton , Clinical Data Manager - APOC ( Princeton, NJ), Other , Princeton, New Jersey

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