Staff Clinical Affairs Specialist

About the role

Staff Clinical Affairs Specialist at Stryker. Be responsible for providing strategic quality oversight and operational support for global clinical programs while driving enterprise clinical initiatives that support….

What you'll do

• Be responsible for providing strategic quality oversight and operational support for global clinical programs while driving enterprise clinical initiatives that support…
• The role ensures compliance with FDA 21 CFR Parts 50, 54, 56, 812 & 820, EU MDR 2017/745, ISO 14155, ISO 13485, ISO 14971, and ICH-GCP
• The individual will oversee clinical quality activities, including review of clinical documentation, investigator site, sponsor, CRO and vendor audits, CAPA management
• In addition, the role will provide functional and technical leadership for enterprise clinical systems by serving as an administrator/SME for platforms such as CTMS
• The position will collaborate closely with Clinical Global Process Owners (GPOs) to develop corporate procedures, clinical policies, knowledge repositories, dashboards

What you need

• 7–9 yrs of experience
• Clinical research
• Power BI
• Dashboarding
• Stakeholder management
• Regulatory affairs
• CRO
• Any graduate

Good to have

• Azure