Leading Innovation in MedTech.
Senior Clinical Trials Manager
Location
California
Posted
3 days ago
Salary
$135K - $183K / year
Seniority
Senior
Job Description
Senior Clinical Trials Manager
T45 Labs
• Lead operational planning and execution of clinical studies from startup through study closeout. • Own study startup strategy and maintain accountability for site activation progress across all participating sites. • Develop and maintain study timelines, milestones, and operational deliverables. • Own enrollment forecasting, study metrics, and operational reporting. • Identify operational risks and implement mitigation plans to maintain study performance. • Ensure study execution remains aligned with protocol requirements, timelines, budgets, and business objectives. • Serve as the primary operational contact for CROs, vendors, consultants, and external study partners. • Manage vendor deliverables, timelines, communication, budgets, and performance. • Own study-level vendor oversight and operational accountability. • Maintain oversight of site budgets and contracts in collaboration with Clinical Affairs and study leadership. • Ensure operational activities remain aligned across vendors, sites, and internal stakeholders. • Maintain oversight of study documentation, TMF quality, and inspection readiness activities. • Ensure study conduct remains compliant with SOPs, GCP, FDA regulations, quality system requirements, and study plans. • Own study-level risk identification, issue escalation, and mitigation planning. • Maintain oversight of CAPA follow-up and resolution activities. • Drive resolution of study-level operational challenges. • Partner closely with Clinical Affairs, Regulatory, Quality, Data Management, Engineering, and other internal stakeholders. • Lead study team meetings and operational reviews. • Provide regular study updates, operational insights, enrollment forecasts, and risk assessments to leadership. • Drive alignment across internal teams, vendors, and clinical sites. • Ensure consistent execution of study processes across participating sites.
Job Requirements
- Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline.
- 7+ years of experience managing clinical studies within the medical device industry.
- Experience with cardiovascular and catheter-based medical device clinical studies strongly preferred.
- Demonstrated experience leading study-level clinical operations activities, including study startup, vendor management, enrollment forecasting, study metrics, and cross-functional execution.
- Demonstrated experience managing clinical trial timelines, budgets, operational deliverables, and external vendors.
- Demonstrated experience overseeing clinical studies from startup through study closeout.
- Demonstrated understanding of FDA regulations, ICH/GCP, and clinical research operations.
- Strong leadership, communication, organizational, and problem-solving skills.
- Ability and willingness to travel up to 30% based on study and business needs.
Benefits
- Bonus opportunities
- Equity
- Company-sponsored benefits
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