Global Clinical Safety Lead: Study Execution & Risk

Abbott; Santa Clara (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott in Santa Clara, CA is seeking a Clinical Safety Program Lead to drive safety oversight across global studies from start-up to close-out.

You will partner with cross-functional teams, develop risk mitigation, oversee data review and regulatory reporting, and mentor colleagues to uphold high safety and quality standards.

This role requires deep clinical safety experience and a proven ability to lead complex studies in a fast-paced healthcare environment.

Qualifications

• Bachelor's degree in nursing, Pharmacy, Life Sciences, Biomedical Engineering, Public Health, or related field.
• 5+ years of clinical research experience.
• Experience leading global clinical studies and cross-functional teams.
• Strong knowledge of GCP, ISO 14155, FDA regulations, MDR, and global clinical research requirements.

Responsibilities

• Lead the operational execution and safety oversight of global clinical studies from start-up through study closeout.
• Serve as the primary safety lead for assigned portfolio, providing expert assessment of safety data and risks.
• Support operational decision-making by identifying gaps, developing solutions, and influencing cross-functional teams.
• Develop and implement study-specific safety management strategies and risk mitigation plans.
• Lead end-to-end data review, data cleaning, and quality initiatives to ensure accurate, reliable data.
• Ensure timely safety reporting to regulatory authorities, investigators, and ethics committees.

Skills

Clinical research

Global study leadership

Safety monitoring

Project management

GCP/regulatory knowledge

Communication & leadership

Education

Bachelor's degree in nursing, Pharmacy, Life Sciences, Biomedical Engineering, Public Health, or related field

Job description

Abbott in Santa Clara, CA is seeking a Clinical Safety Program Lead to drive safety oversight across global studies from start-up to close-out.

You will partner with cross-functional teams, develop risk mitigation, oversee data review and regulatory reporting, and mentor colleagues to uphold high safety and quality standards.

This role requires deep clinical safety experience and a proven ability to lead complex studies in a fast-paced healthcare environment.