Clinical Affairs Manager Job
Job Description Job Attributes+
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Job ID
31119623
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Req #
ABLAUS31119623ENUSEXTERNAL
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Job Location
Alameda, CA, US
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Job Category
Medical and Clinical Affairs
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Job Type
Full time
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Travel
No
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Schedule
40 hours per week
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.
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
This position works out of our Alameda, CA location in the Lingo Division. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
The Clinical Affairs Manager will manage teams within the Medical Affairs Sub-Function. Focus is on policy and strategy implementation and control rather than development. Typically handles short-term operational/tactical responsibilities.
What You’ll Work On
- As the Manager of the Clinical Affairs Sub-Function, oversees the strategy implementation and operations for overseeing the direction, planning, execution, clinical trials/research and the data collection activities.
- Contributes to implementation of clinical protocols and facilitates completion of final reports.
- Recruits clinical investigators and negotiates study design and costs.
- Responsible for directing human clinical trials, for company products under development.
- Participates in adverse event reporting and safety responsibilities monitoring.
- Coordinates and provides reporting information for reports submitted to the regulatory agencies.
- Monitors adherence to protocols and determines study completion.
- Coordinates and oversees investigator initiations and group studies.
- May act as consultant/liaison with other corporations when working under licensing agreements.
Required Qualifications
- Bachelor's degree
- Minimum 8 years of relevant experience
Preferred Qualifications
- Master’s or PhD degree in science or a related field.
- Experience with quality management system GAP analysis and audit preparation.
- Strong clinical operations background.
- Previously work in roles that require understanding of digital consumer behavior.
- Software life cycle experience.
- Experience with CAPA.
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.
The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.
Job Skills
- quality management systems
- clinical trial management
- adverse event reporting
- clinical protocols
- regulatory compliance
- clinical operations
- data collection
- stakeholder communication
- project management
- software lifecycle management
- gap analysis
- data analysis
Additional Information
Who We Are
PUT YOUR TALENTS TO WORK
Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.