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Associate Director, Clinical Operations
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Full-time
- We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients.
- Develops communication pathways and study-specific processes to allow team members to communicate with clinical trial sites regarding all logistics including contract agreements, support materials and training, and IRB/EC application process.
- Leads cross-functional team efforts on review of clinical data listings (protocol deviations, study data review, etc.)
- Collaborates with Clinical Quality Assurance (CQA) in ensuring GCP/GPV inspection readiness of the organization, its vendors, and its clinical investigators/sites, and subsequently managing follow-up within the Clinical Development organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
- Experience in gene therapy, rare/orphan disease highly desired.
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