Lead Clinical Risk Management Analyst
Location: Alameda, CA (Onsite, Monday–Friday)
Division: Abbott Diabetes Care – Medical Devices
Base Pay Range: $86,700 – $173,300 (may vary by location)
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. With 114,000 colleagues serving people in more than 160 countries, we deliver life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines.
Working at Abbott
At Abbott, you can:
Do work that matters and grow your career globally.
Access free medical coverage for employees* (HIP PPO plan).
Benefit from an excellent retirement savings plan with strong employer contribution.
Take advantage of tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit for bachelor’s degrees.
Work at a company recognized globally as:
One of the most admired companies (Fortune).
A best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
The Lead Clinical Risk Management Analyst will:
Lead and manage development, documentation, and execution of risk-based quality management processes (risk assessment, data management, site/central monitoring plans).
Systematically identify potential risks across all clinical trial phases—from protocol design to data lock.
Collaborate with cross-functional clinical teams to integrate risk mitigation strategies.
Maintain comprehensive research documentation for audits, inspections, and regulatory submissions.
Conduct ongoing review of IQRMP, coordinate risk review meetings, prepare reports, and ensure execution of actionable items.
Key Responsibilities
Identify and analyze study-specific risks impacting study conduct and subject safety.
Develop and implement effective mitigation strategies.
Review study data for completeness, quality, and issues (anticipated/unanticipated).
Facilitate multi-stakeholder discussions, evaluate findings, and develop corrective action plans.
Conduct or oversee Central Monitoring activities.
Support data cleaning activities as needed.
Required Qualifications
Bachelor’s degree in life sciences, biomedical engineering, or related field.
Minimum 6 years’ experience in clinical research or related field.
Background in research compliance, quality, project management, or clinical research.
Knowledge of:
Data collection best practices for clinical trials.
Regulatory frameworks (FDA, EMA, ICH-GCP).
Global clinical research operations.
Preferred Qualifications
Certification in risk management (RMP) or clinical research certifications.
Experience in risk-based or quality management roles.
Ability to influence teams and act as a subject matter expert.
Skilled in identifying risks, assessing impact, and implementing practical mitigation strategies.
Experience translating clinical trial requirements into technical specifications.
Strong analytical thinking—making inferences with limited information.
Intermediate project management skills (complex plans, cross-team coordination).
Intermediate therapy-specific knowledge (anatomy, physiology, pathophysiology, therapy, devices).
Advanced medical knowledge (medical histories, terminology, diagnostics, medications).
Divisional Information
Medical Devices
Helping more than 10,000 people live with healthier hearts.
Improving quality of life for those with chronic pain and movement disorders.
Supporting over 500,000 people with diabetes, liberating them from routine fingersticks.
Diabetes Care
Focused on life-changing solutions for people with diabetes.
Delivering accurate data to support better health decisions.
Pioneering glucose monitoring with revolutionary sensing technology.
Apply Now
Learn more about Abbott’s health and wellness benefits: www.abbottbenefits.com
Connect with us:
Website: www.abbott.com
Facebook: facebook.com/Abbott
Twitter: @AbbottNews
Abbott is an Equal Opportunity Employer, committed to employee diversity.
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