Lead Clinical Research Associate

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:
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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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.

The Opportunity
This position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
The Lead Clinical Research Associate manages the design, execution, and monitoring of internal and external clinical studies, coordinates the development of operating procedures, coordinates in the development of standard procedures in executing experiments, evaluation, and documentation of results, and contributes to the development of clinical strategy for ADC products
What you'll work on

• Manage design, execution, and monitoring of internal clinical studies, including management of budget
• Manage in the design, training and monitoring of Abbott sponsored external clinical studies for regulatory and commercial access.
• Manage in identification and qualification of external clinical sites.
• Manage in the development and maintaining of operating procedures
• Develops clinical strategy to support product development and market introduction.
• Participates in cross functional team activities for product development including risk management.
• Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management

Required Qualifications

• Bachelor degree with a minimum of 8 years of experience in conducting clinical studies or relevant laboratory experience is required.
• Clinical monitoring experience.
• Significant experience leading projects and people.
• Sponsor Clinical Research experience.
• Experience in medical device related studies is desirable.
• Experience in diabetes is preferred.
• Knowledge of regulations governing medical devices is desirable.

Preferred Qualifications

• Master's or PhD degree in science or a related field.
• Experience with quality management system GAP analysis and audit preparation.
• Experience with CAPA.
• Strong clinical operations background.

Apply Now
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is
$109,300.00 - $218,500.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Medical & Scientific Affairs
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 50 % of the Time
MEDICAL SURVEILLANCE:
No
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.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf