Associate Clinical Data Manager (on-site)

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.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks.

The Opportunity

Our location in Sylmar, CA or Maple Grove MN currently has an on-site opportunity for an Associate Clinical Data Manager.  As the customer-face of Data Review and its primary liaison with the therapy group and Clinical Project Team, the Associate Clinical Data Manager’s in-depth clinical operations and therapy-specific knowledge ensures alignment to customer definitions of criticality and informs review and analysis of study data.

What You’ll Work On

• Leads and facilitates an ongoing evaluation of risk involving in-depth review of protocol and plan documentation, discussion and validation of Critical Data, Critical Processes, and risk-related findings with cross-functional workgroup, and the development of systems and process-based controls to mitigate identified risks. These responsibilities include:
  • Leading cross-functional teams during protocol development to identify and document those data which are critical to the reliability of study results and the protection of human subjects
  • Managing the development and revision of the critical processes (e.g. CRF design, Edit Checks, data listings, and clinical database setup) by which those data will be captured and managed throughout the clinical investigation
  • Identifying and evaluating residual risks to critical study data and supervising the development of additional mitigations including focused data cleaning and quality activity, targeted site instruction, and study-specific Central and Site Monitoring plans
• Leads the Clinical Project Team through the development of Case Report Forms and partners with the Study Database Manager through study database development and release, including identifying, programming and testing edit checks.
• Conducts complex review and analysis of subject data as it accumulates, resolving discrepant or aberrant data points via individual queries to study sites, as well as the identification of systemic and/or significant data quality issues requiring escalation; manages escalation efforts and drives them to resolution in partnership with Project Management, Site Management, Clinical Science, Biometrics, Safety, and organizational leaders.
• Manages progress towards data cleaning and data freeze/lock targets for regulatory submission, and other business needs as identified by the Clinical Project Team.