Senior Manager, Clinical Research
$200,000–$215,000 year
HybridNew York, United States
Job Summary
Serve as the primary operational point of contact for external clinicians managing Investigator-Initiated Trials (IITs), maintaining rigorous tracking systems for milestones, data collection timelines, and budget disbursements. Lead the drafting, formatting, and submission of Institutional Review Board (IRB) applications, amendments, and annual renewals while cross-functionally collaborating with Engineering and Quality Assurance teams to audit internal Verification and Validation documentation. Manage a Clinical Coordinator to ensure clinical projects hit timelines and meet regulatory standards, keeping internal stakeholders updated on trial metrics and compliance health. Ensure all trial master files are audit-ready and compliant with FDA, ISO 14155, and Good Clinical Practice guidelines.
Required Qualifications
- 4–6+ years of clinical research experience within the medical device, medtech, or digital health space
- Prior experience managing or mentoring junior clinical staff (e.g., Clinical Coordinators or Assistants)
- Demonstrated success handling IRB submissions, maintaining TMFs, and tracking multisite trials or IITs
- Deep familiarity with medical device documentation, internal V&V processes, GCP, and FDA regulations
- Bachelor's degree in a scientific, nursing, or healthcare-related field
- Candidate must be legally authorized to work in the United States and not require sponsorship for employment visa status
- Candidate must not be an agency resume
- Must adhere to all company security policies and procedures
- Must utilize provided company assets securely
- Must complete all required security awareness training programs
- Must safeguard company data and systems from unauthorized access, modification, or destruction
- Must immediately report any suspected or actual security incidents, including phishing attempts, malware infections, or unauthorized access
- Must follow the established incident response procedure
- Must be available for a hybrid work model with two or more days a week in the office
- Must be based in the San Francisco Bay Area or New York City, NY
Desired Qualifications
- CCRP or CCRA certification
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