Global Clinical Safety & Study Lead

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

Benefits offered by this job

HIP PPO medical plan

Retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Laboratories is seeking a Clinical Safety Program Lead to guide the safety oversight and operational execution of global clinical investigations. You will partner with Safety leadership to ensure high standards of subject safety, data quality, and regulatory compliance across the portfolio.

The role requires a blend of clinical research operations, project management, and medical knowledge to lead complex studies and provide strategic guidance throughout the lifecycle.

Qualifications

• Bachelor's degree in nursing, pharmacy, life sciences, 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 or equivalent.
• Strong knowledge of GCP, ISO 14155, FDA regulations, MDR, and global requirements.
• Excellent communication, leadership, and problem-solving skills.

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.
• Identify operational risks and implement mitigation strategies to maintain timelines and quality and escalate as needed.
• Lead end-to-end data review, data cleaning, and quality initiatives for reliable, inspection-ready data.
• Partner with Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and Product Development.
• Oversee Data Monitoring Committees and Clinical Events Committees.
• Drive protocol development, study design, endpoints, and safety monitoring approaches.
• Ensure timely safety reporting to authorities, investigators, ethics committees, and stakeholders.
• Provide clinical interpretation of safety data and support regulatory submissions and health authority interactions.
• Drive inspection readiness, process improvements, and best practices across operations and safety.
• Mentor team members and promote collaboration, accountability, and patient focus.
• Anticipate risks and escalate critical concerns to ensure timely resolution.
• Stay aware of emerging clinical evidence and disease-area developments.
• Establish and drive study timelines, deliverables, and action plans with accountability.
• Contribute to SOPs and best practices.

Skills

Clinical trial leadership

Project management

Cross-functional collaboration

Communication

Problem-solving

Education

Bachelor's degree in life sciences or related field

Tools

GCP knowledge

Data management systems

Job description

Abbott Laboratories is seeking a Clinical Safety Program Lead to guide the safety oversight and operational execution of global clinical investigations. You will partner with Safety leadership to ensure high standards of subject safety, data quality, and regulatory compliance across the portfolio.

The role requires a blend of clinical research operations, project management, and medical knowledge to lead complex studies and provide strategic guidance throughout the lifecycle.