Clinical Data Management Analyst

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 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Clinical Data Management Analyst will be an individual contributor that works under limited supervision and applies subject matter knowledge. Requires the capacity to understand specific needs or requirements to apply skills/knowledge. This is an on-site position in Alameda, California.

What You’ll Work On

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Processes, reviews, and receives patient data and records and organizes clinical data forms from particular therapeutic groups and outside investigators.

• Provides accurate, timely, and consistent clinical data to the medical department and other groups.

• Responsible for data management plans including data preparation, data validation activities, etc.

• Follows Good Clinical Practices (GCP) data-handling procedures and guidelines.

• Requires knowledge of drug and disease terminology.

• May manage service providers that perform these activities.

• Participates in the review of clinical research protocols, reports and statistical analysis plans.

• Involved in the preparation of all applicable data management documents required for the conduct of the study (such as Trial Master File (TMF), Case Report Forms and Data Management Plans).

Required Qualifications

• Associate degree in life sciences or appropriate degree.

• BS degree preferred in life sciences with a minimum of one year of experience in clinical data management or combination of appropriate education and experience.

• Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.

• Solid understanding of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.

• Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.

• Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.

• Experience using Electronic Data Capture systems, Veeva Vault eTMF, and SAS.

• Working knowledge of GCP, GCDMP, Clinical and Regulatory Affairs.

• Flexibility in daily activities.

The base pay for this position is

$81,500.00 – $141,300.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

ADC Diabetes Care

LOCATION:

United States > Alameda : Plaza 6 Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link- English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link- Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf