Synova Partners · 2 days ago
Senior Manager of Clinical Quality & Operations
Boston, MA
Full-time
Hybrid
Senior Level
7+ years expSynova Partners is supporting a highly disruptive neurovascular start-up as they build out their Clinical Affairs function. The Senior Manager of Clinical Quality & Operations will ensure clinical trials are conducted to the highest quality and compliance standards, leading various quality strategies and partnerships across teams.
Staffing & Recruiting
Hiring Manager
Myles Clegg
Responsibilities
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
Exposure to broader clinical operations activities, vendor oversight, regulatory support, and future clinical strategy
Qualification
Required
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)
Company
Synova Partners
At Synova our mission is simple; to build high-performing teams for early-stage MedTech companies, empowering them to fulfil their goal of bringing life-saving innovation to the market.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase