Lead clinical safety oversight across global studies, including assessment, adjudication, coding, documentation, and reporting of adverse events. Partner with cross-functional teams and external sites/CROs, author event narratives, present safety findings, and drive process improvements to ensure data quality, compliance, and inspection readiness.
Work Flexibility: Remote
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Staff Clinical Safety Specialist - Remote
As a Staff Clinical Safety Specialist, you will serve as a clinical safety subject matter expert across multiple studies, leading safety event review, adjudication, reporting, and process oversight while partnering with cross-functional teams to support consistent and compliant clinical study execution.
This role combines clinical safety expertise, regulatory knowledge, and operational leadership to ensure accurate assessment, documentation, coding, and reporting of clinical safety events across a global study portfolio.
Work Flexibility:
- Remote
What You Will Do
- Lead clinical safety oversight activities across assigned studies, including identification, assessment, adjudication, and reporting of adverse events and other safety-related events.
- Review and evaluate adverse events, serious adverse events, protocol-defined endpoints, and other safety signals to ensure accurate and timely documentation and escalation.
- Author and review clinical event narratives, ensuring completeness, consistency, scientific accuracy, and regulatory compliance.
- Partner with Clinical Operations, Medical Affairs, Data Management, Biostatistics, Regulatory Affairs, and Quality teams to support timely safety event review, reporting, and resolution.
- Coordinate with clinical sites, contract research organizations, field monitors, medical monitors, and adjudication committees to obtain and reconcile source documentation required for safety assessments.
- Perform and oversee clinical safety event coding activities using established coding standards and conventions to maintain data quality and consistency.
- Present safety findings, event summaries, adjudication outcomes, and emerging trends during safety review meetings and governance forums.
- Drive continuous improvement initiatives that enhance safety processes, inspection readiness, data quality, compliance, and operational efficiency across studies.
What You Will Need
Required Qualifications
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related discipline.
- Minimum 4 years of experience in clinical research, clinical safety, pharmacovigilance, medical device vigilance, or a related field.
- Working knowledge of Good Clinical Practice (GCP), U.S. Food and Drug Administration (FDA) regulations, ISO 14155, International Council for Harmonisation (ICH) guidelines, and Medical Device Reporting requirements.
- Experience assessing and documenting adverse events, serious adverse events, and other clinical safety events within regulated clinical studies.
Preferred Qualifications
- Advanced degree in Life Sciences, Nursing, Pharmacy, Public Health, Medicine, or a related scientific discipline.
- Experience supporting clinical event adjudication committees, data safety monitoring boards, or medical monitoring activities.
- Experience with Medical Dictionary for Regulatory Activities (MedDRA) coding and clinical safety databases.
United States of America Pay Ranges:
- USN: $95,700 - $159,500 USD Annual
- US5: $100,500 - $167,500 USD Annual
- US10: $105,300 - $175,500 USD Annual
- US15: $110,100 - $183,400 USD Annual
- US20: $114,800 - $191,400 USD Annual
- US30: $124,400 - $207,400 USD Annual
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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Lead clinical safety oversight across studies including identification, assessment, adjudication, coding, and reporting of adverse events. Author event narratives, partner with cross-functional teams, coordinate with sites/CROs, present safety findings, and drive process improvements to ensure regulatory compliance and data quality.
Top Skills:
Clinical Safety DatabasesMeddra
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