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Clinical Audit Lead or Clinical Operations Quality Manager – Remote Opportunity
📍 Remote – United States | 🧬 MedTech | 🌍 Global Clinical Trials
No sponsorship provided.
Join a high-impact Clinical Affairs team focused on Breast & Skeletal Health technologies.
In this role, you will lead and oversee global clinical trials across multiple development phases, ensuring the highest standards of quality, compliance, and execution.
You’ll collaborate cross-functionally with teams across Clinical Development, R&D, Regulatory, and more to generate high-quality clinical evidence that supports innovative healthcare solutions.
🎯 What We’re Looking For
- 6–10+ years of experience in clinical quality audits in medical device trials
- Background in medical device trials, oncology, or diagnostics (strongly preferred)
- Experience managing clinical trials (sponsor or CRO)
- Strong background in medical device clinical trials (pharma-only experience will not be considered)
- Proven experience in clinical quality audits with full ownership
- Strong knowledge of GCP, ICH, and regulatory frameworks
- Proven ability to manage complex, global studies and stakeholders
- Experience with quality systems, audits, and CAPA
- No sponsorship provided.
- Audit certification (e.g., Certified Quality Auditor – CQA) is a plus
- 25% traveling
🔑 What You’ll Do
- Lead end-to-end clinical trial execution (start-up to close-out)
- Oversee quality control activities across clinical trials
- Ensure compliance with GCP, ICH, and regulatory standards
- Oversee quality assurance, audits, and monitoring activities
- Review key clinical documents (protocols, eCRFs, IRB submissions, etc.)
- Manage CROs and external vendors (selection, budgets, performance)
- Drive quality processes, including deviations and CAPA management
- Support regulatory submissions and inspections
- Improve systems, tools, and SOPs to enhance clinical quality
- Manage and support IRB interactions and submissions
- Review clinical trial execution to identify gaps and drive improvements
- Contribute to maintaining inspection readiness across studies
🌍 Benefits
- Full time remote opportunity
- Work on innovative, life-impacting technologies
- Collaborate with a global, high-performing team
- 401k
- ✈️ ~25% Travel
- High visibility and strategic impact across clinical programs
Work Authorization:
This role requires current authorization to work in the United States. We are unable to provide visa sponsorship now or in the future
The IN group is here to support you specifically with the recruitment and hiring process for job opportunities. Our role is focused on guiding you through these steps. If you have any questions related to your application or next steps in the hiring process,
Apply, and please feel free to reach out.
