Head of Clinical Process and Standards
$200,000–$265,000 year
On-siteBoston, Massachusetts, United States
Job Summary
Lead a global team of Clinical Trial Administrators and oversee key study components including the Trial Master File, clinical systems, and process improvement initiatives. Manage operational tasks for clinical trials while ensuring the TMF remains inspection ready for both internally and externally managed studies. Develop and implement strategies for clinical trial operations, maintain the Clinical Trial Management System, and foster a culture of inspection readiness by sharing best practices with quality teams. Create and improve clinical controlled documents, SOPs, and training tools to ensure compliance with GCP and regulatory standards. Serve as the Business Process Owner for CTMS and eTMF, driving system migrations and digital transformation aligned with portfolio growth.
Required Qualifications
- Bachelor's degree in Life Sciences or a related field
- Minimum of 15 years progressive experience in clinical operations
- 5 years in a managerial role or equivalent
- Pharma/Biotech and/or CRO experience
- Systemic drug and biologics experience
- Excellent knowledge of international guidelines ICH/GCP
- Basic knowledge of GMP/GDP
- Excellent knowledge of relevant local regulations
- Excellent understanding of the product development process
- Excellent understanding of Clinical Trial Management
- Ability to perform standard office activities, including extended periods of computer use
- Ability to participate in virtual and in-person meetings
- Ability to collaborate across teams
- Ability to travel occasionally
Desired Qualifications
- Systemic drug and biologics experience preferred
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