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Lead Clinical Risk Management Analyst

6+ years
$86,700 – $173,300 annually
10 July 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 – 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.