Global Clinical Safety Program Lead

Abbott Laboratories; Maple Grove (MN); Hybrid; USD 99,000 - 199,000; Full time

Benefits offered by this job

Health Insurance

Retirement savings plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Laboratories in Maple Grove seeks a Clinical Safety Program Lead to drive safety oversight and operational execution for global studies. You will partner with Safety leadership to ensure high standards of safety, data quality, and regulatory compliance across the portfolio.

The role combines clinical research operations, project management, and medical insight to navigate complex studies, mitigate risks, and deliver inspection-ready results.

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.
• Experience in clinical safety, pharmacovigilance, medical monitoring, or safety surveillance.
• Experience in project management role or equivalent.
• Strong knowledge of GCP, ISO 14155, FDA regulations, MDR, and global clinical research requirements.
• Excellent communication, leadership, and problem-solving skills.

Responsibilities

• Lead operational execution and safety oversight of global clinical studies from start-up to closeout.
• Serve as the primary safety lead for assigned portfolio, assessing safety data and risks.
• Support operational decisions by identifying gaps, developing solutions, and influencing teams.
• Develop and implement study-specific safety management strategies and risk plans.
• Ensure timely, compliant safety reporting to regulators, investigators, and ethics committees.
• Mentor team members and drive continuous process improvement in safety and operations.

Skills

Clinical research leadership

Global study leadership

Safety and pharmacovigilance

Project management

GCP/regulatory knowledge

Education

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

Job description

Abbott Laboratories in Maple Grove seeks a Clinical Safety Program Lead to drive safety oversight and operational execution for global studies. You will partner with Safety leadership to ensure high standards of safety, data quality, and regulatory compliance across the portfolio.

The role combines clinical research operations, project management, and medical insight to navigate complex studies, mitigate risks, and deliver inspection-ready results.