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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.

Lead Clinical Risk Management Analyst

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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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

The Lead Clinical Risk Management Analyst is responsible to lead and manage the development, documentation, and execution of risk-based quality management process, as described in the risk assessment, data management plan, and site and central monitoring plans. Demonstrate ability to systematically identify potential risks across all trial phases—from protocol design to data lock.

The Lead Clinical Risk Management Analyst will collaborate with cross-functional clinical teams to integrate the risk mitigation strategies during the conduct of the study protocols.

They are responsible for maintaining comprehensive research documentation for audits, inspections and regulatory submissions.

Develop and/or conduct the continuous review the IQRMP routinely, coordinate risk review meetings between functional groups, completing risk management review reports and ensuring execution of actionable items, guide the monitoring and data process.

This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

What You'll Work On

+ Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.

+ Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality.

+ Facilitate multi-stakeholder discussions to facilitate review findings, evaluate impact and develop action plans for correction and continued monitoring.

+ Conduct or facilitate Central Monitoring activities, as described in Central Monitoring Plan.

+ Facilitate data cleaning activity related to assigned studies as needed.

Required Qualifications

+ Bachelor’s degree in life sciences, medical, bio-medical engineering, or related field.

+ Minimum 6 years in clinical research or related field.

+ Education and work experience in research compliance, or quality, project management, or life sciences or clinical research.

+ Knowledge of data collection best practices for clinical trials familiarity with regulatory frameworks (e.g., FDA, EMA, ICH-GCP).

+ Knowledge of global clinical research operations.

Preferred Qualifications:

+ Certification in risk management (e.g., RMP, or clinical research certifications).

+ Risk based or quality management experience

+ Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to the desired outcome.

+ Proficient at the identification of risks in a process, evaluation of likelihood and impact, and the development of effective mitigation and monitoring strategies that are imperfect yet meet the business need.

+ Proficient in the translation of clinical trial requirements to the technical specifications.

+ Skilled at making inferences and connections based on limited information, clearly describing the knowns, unknowns, and alternative explanations.

+ Intermediate project management skills; developing a multifaceted plan with complex dependencies and holding peers accountable to adherence to the plan while maintaining positive and collaborative relationships.

+ Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.

+ Advanced medical knowledge related to common medical histories, medical terminology, diagnostics (imaging, laboratory), and medications (class, dose, route).

**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices 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 fingersticks.

Diabetes

We’re 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 base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [email protected]