Senior Manager of Clinical Quality & Operations

Synova Partners is proud to be supporting a highly disruptive neurovascular start-up as they build out their Clinical Affairs function and prepare for key upcoming trial milestones.

This is a great opportunity for someone who enjoys working in a hands-on, start-up environment
, where you can genuinely influence how clinical quality is embedded across trials, not just maintain existing systems.

You’ll play a central role in ensuring clinical trials are run to the highest quality and compliance standards:

• Leading a risk-based clinical quality strategy across active and upcoming trials
• Ensuring ongoing inspection readiness and GCP compliance
• Owning and improving clinical SOPs, TMFs, and study documentation
• Partnering closely with Clinical Ops, Regulatory, Quality, Manufacturing and external CROs
• Supporting audit and inspection readiness (including BIMO prep and follow-up)
• Helping identify and resolve quality issues, CAPAs, and trial risks early
• Supporting sites ahead of FDA or other regulatory inspections
• Driving a culture of quality and continuous improvement within the clinical team

You’ll also have exposure to broader clinical operations activities, vendor oversight, regulatory support, and future clinical strategy.

• 7–10+ years’ experience in Clinical Quality and/or Clinical Operations within medical devices
• Strong working knowledge of GCP and global clinical regulations (FDA, ICH, EMA, etc.)
• Experience supporting Class III devices and IDE / pivotal trials strongly preferred
• Comfortable working with CROs, consultants, and cross-functional teams
• Someone who enjoys being hands-on, proactive, and adaptable in a fast-moving environment
• Background in life sciences or engineering (BS or higher)

• Work on a first-of-its-kind neurovascular implant with a major unmet clinical need
• High visibility role with real influence on trial execution and quality systems
• Join at a critical growth stage with upcoming clinical and regulatory milestones