Global Clinical Safety & Study Lead

Abbott (abbottcareers2 board); Santa Clara (CA); Vor Ort; USD 160.000 - 230.000; Vollzeit

Benefits dieser Stelle

HIP PPO medical plan

Strong retirement contributions

Tuition reimbursement

Zusammenfassung

Abbott is seeking a Clinical Safety Program Lead to oversee global clinical studies with a focus on safety, data integrity, and regulatory compliance. Partner with Safety leadership to deliver studies efficiently while maintaining subject safety and quality.

Lead end-to-end safety processes and cross-functional risk mitigation across the portfolio. The role emphasizes inspection-ready data, protocol development, and collaboration with Clinical Operations, Regulatory Affairs, and Biostatistics to

Qualifikationen

• Lead global clinical studies with safety oversight and operational leadership.
• Collaborate across Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics and Data Management.

Aufgaben

• Lead the operational execution and safety oversight of global clinical studies from start-up through closeout.
• Serve as primary safety lead for assigned portfolio with expert assessment of safety data and risks.
• Support operational decision-making by identifying gaps and developing solutions across cross-functional teams.
• Develop and implement study-specific safety management strategies and risk mitigation plans.
• Ensure timely safety reporting to regulatory authorities and stakeholders.
• Mentor team members and drive a culture of collaboration and continuous improvement.

Jobbeschreibung

Abbott is seeking a Clinical Safety Program Lead to oversee global clinical studies with a focus on safety, data integrity, and regulatory compliance. Partner with Safety leadership to deliver studies efficiently while maintaining subject safety and quality.

Lead end-to-end safety processes and cross-functional risk mitigation across the portfolio. The role emphasizes inspection-ready data, protocol development, and collaboration with Clinical Operations, Regulatory Affairs, and Biostatistics to