Clinical Safety Specialist
About the position
Stryker Inari is seeking a Clinical Safety Specialist (Remote) to ensure accurate, timely, and consistent safety assessments of adverse events across sponsored clinical studies and registries. This role is responsible for maintaining compliance with global safety reporting requirements throughout the clinical study lifecycle. The Clinical Safety Specialist will collaborate closely with internal teams—including Safety, Clinical Program Management, Data Management, Biostatistics, Scientific Communications, and Complaint Handling—as well as external CROs and study partners to uphold the highest standards of patient safety and enable access to advanced care.
Responsibilities
• Interact with clinical sites, field monitors to obtain and verify source data for safety event adjudication.
• Review and code adverse events (AEs), serious adverse events (SAEs), and endpoint-related events using MedDRA, ensuring accuracy and consistency across studies.
• Write safety narratives and support Safety Review meetings in alignment with the Safety Management Plan and regulatory requirements.
• Collaborate with Safety Leadership, Adjudicators (Medical Monitors and Clinical Events Committee), and cross-functional teams to develop and execute clinical safety plans.
• Ensure timely and compliant reporting of AEs/SAEs/UADEs/MAEs while maintaining adherence to SOPs, GCP, and regulatory standards.
• Drive high-quality safety data collection to support scientific communications, clinical research, and statistical analysis strategies.
• Proactively identify and resolve potential safety data issues, ensuring clear communication with sites and study teams.
• Apply strong technical knowledge of products, clinical processes, and disease states to enhance safety oversight and functional excellence.
Requirements
• Bachelor’s degree
• Minimum 2 years of experience in clinical research
• Proficient with electronic databases used for clinical trials, such as, Zelta, etc.
• Experience with Good Clinical Practices (GCP)
Nice-to-haves
• Bachelor’s degree in life science
• Possesses exceptional attention to detail and strong analytical skills to accurately review CRFs, source documents, and evaluate safety data for quality and compliance.
• Brings medical knowledge and preferably experience in clinical trials or medical devices to support informed decision-making and data integrity.
Apply Now
Apply Now
Stryker Inari is seeking a Clinical Safety Specialist (Remote) to ensure accurate, timely, and consistent safety assessments of adverse events across sponsored clinical studies and registries. This role is responsible for maintaining compliance with global safety reporting requirements throughout the clinical study lifecycle. The Clinical Safety Specialist will collaborate closely with internal teams—including Safety, Clinical Program Management, Data Management, Biostatistics, Scientific Communications, and Complaint Handling—as well as external CROs and study partners to uphold the highest standards of patient safety and enable access to advanced care.
Responsibilities
• Interact with clinical sites, field monitors to obtain and verify source data for safety event adjudication.
• Review and code adverse events (AEs), serious adverse events (SAEs), and endpoint-related events using MedDRA, ensuring accuracy and consistency across studies.
• Write safety narratives and support Safety Review meetings in alignment with the Safety Management Plan and regulatory requirements.
• Collaborate with Safety Leadership, Adjudicators (Medical Monitors and Clinical Events Committee), and cross-functional teams to develop and execute clinical safety plans.
• Ensure timely and compliant reporting of AEs/SAEs/UADEs/MAEs while maintaining adherence to SOPs, GCP, and regulatory standards.
• Drive high-quality safety data collection to support scientific communications, clinical research, and statistical analysis strategies.
• Proactively identify and resolve potential safety data issues, ensuring clear communication with sites and study teams.
• Apply strong technical knowledge of products, clinical processes, and disease states to enhance safety oversight and functional excellence.
Requirements
• Bachelor’s degree
• Minimum 2 years of experience in clinical research
• Proficient with electronic databases used for clinical trials, such as, Zelta, etc.
• Experience with Good Clinical Practices (GCP)
Nice-to-haves
• Bachelor’s degree in life science
• Possesses exceptional attention to detail and strong analytical skills to accurately review CRFs, source documents, and evaluate safety data for quality and compliance.
• Brings medical knowledge and preferably experience in clinical trials or medical devices to support informed decision-making and data integrity.
Apply Now
Apply Now