Staff Clinical Affairs Specialist
On-siteGurugram, Haryana, India
Job Summary
Provide strategic quality oversight and operational support for global clinical programs while driving enterprise clinical initiatives. Ensure compliance with FDA, EU MDR, ISO, and ICH-GCP regulations by partnering with Clinical Affairs, Regulatory Affairs, R&D, and CROs. Oversee clinical quality activities including review of clinical documentation, site and vendor audits, CAPA management, risk assessments, and inspection readiness. Provide functional and technical leadership for enterprise clinical systems by serving as an administrator/SME for platforms such as CTMS, EDC, eTMF, SharePoint, Azure DevOps, and Power BI. Collaborate with Clinical Global Process Owners to develop corporate procedures, policies, dashboards, and metrics. Evaluate clinical technologies and vendors, lead cross-functional projects, facilitate global forums, and drive process standardization.
Required Qualifications
- 7 years - 9 years
- 5-8 years of experience in Clinical Quality, Clinical Affairs, or Clinical Research within the medical device industry
- strong expertise in global regulations
- clinical systems
- project management
- stakeholder engagement
- digital transformation initiatives
- Travel Percentage: None
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