Lead Clinical Risk Management Analyst – Abbott (Alameda, CA)
Job Summary:
Abbott is hiring a Lead Clinical Risk Management Analyst at its Alameda, CA location. This on-site role is central to ensuring clinical trial quality and compliance through risk-based management approaches. The ideal candidate has a strong background in clinical research, quality systems, and regulatory frameworks such as ICH-GCP and FDA/EMA guidelines. This is a unique opportunity to influence risk mitigation strategies and ensure the integrity of global clinical studies in the medical device space.
Key Responsibilities:
Identify and assess study-specific risks impacting clinical trial safety and data quality
Design and implement effective mitigation and monitoring strategies
Lead ongoing review and updates of the Integrated Quality and Risk Management Plan (IQRMP)
Conduct central monitoring activities and data reviews
Facilitate risk review meetings and collaborate with cross-functional teams
Evaluate data completeness, subject safety indicators, and quality trends
Translate clinical requirements into actionable risk management plans
Assist with documentation for audits, inspections, and regulatory submissions
Manage cross-functional discussions to address findings and recommend action plans
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences, Biomedical Engineering, or related field
Minimum 6 years’ experience in clinical research, quality, or risk management
Deep knowledge of clinical data collection practices and global clinical research operations
Understanding of ICH-GCP, FDA, EMA regulations
Strong analytical skills in identifying risks and implementing process improvements
Intermediate project management and cross-functional collaboration skills
Preferred Qualifications:
Certification in risk management or clinical research (e.g., RMP, ACRP, SOCRA)
Subject Matter Expertise in clinical quality management and trial risk assessment
Familiarity with medical devices, anatomy, diagnostics, and therapeutics
Experience with translating risk management requirements into operational strategies
Excellent communication and decision-making abilities in cross-functional settings
Salary Range:
$86,700 – $173,300 annually (range may vary by location)
Perks & Benefits:
Free medical coverage via Health Investment Plan (HIP PPO)
Generous retirement savings plan with high employer contributions
Tuition reimbursement and FreeU bachelor’s degree support
Freedom 2 Save student debt assistance
Career development opportunities in a global healthcare environment
Recognized as a top employer for diversity, innovation, and leadership
Company Description:
Abbott is a global leader in healthcare and medical device innovation. With a presence in over 160 countries, Abbott empowers lives through advanced diagnostics, devices, nutrition, and branded generics. Its Diabetes Care division in Alameda focuses on cutting-edge glucose monitoring systems and life-enhancing health tech.
Work Mode:
On-site | Monday to Friday | Alameda, California, USA
Call to Action:
Ready to lead impactful clinical risk strategies in a world-class healthcare company?
Apply now to join Abbott and shape the future of medical research.
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