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Lead Clinical Risk Management Analyst

6 years
$86,700.00 – $173,300.00
10 Sept. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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

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Abbott is an Equal Opportunity Employer, committed to employee diversity.