Clinical Operations

Our Mission:

To manage and optimize the clinical research infrastructure necessary for bringing novel/personalized cell and gene therapies to patients. 

Key Objectives:

• Support the translation of first-in-human investigational cell and gene therapy products from the bench to bedside.
• Manage/accelerate the clinical trial development and new study activation pathways.
• Establish internal and external collaborative partnerships.
• Establish/maintain the infrastructure required to standardize and optimize clinical trial development and execution; and ensure ongoing oversight/compliance.
• Develop/refine standardized processes, procedures, and templates/tools to align with the changing regulatory landscape and new scientific innovation.
• Ensure generation of high-quality, reliable and statistically sound clinical data that can be used for reporting, publication, endpoint analysis and further product development.
• Identify/implement new technology/systems required to enhance clinical research operations.

Core Responsibilities

Clinical Development:

• Manage the clinical trial development and study activation pathway
• Establish and maintain core document templates
• Facilitate new protocol and other core document development
• Develop and implement protocol/core document amendments

Project Management: 

• Overall project implementation
• Establish the required infrastructure for executing new clinical trials
• Work with collaborative partners to manage study operations/study conduct
• Site Management: Establish/maintain project timelines, develop/perform study training, develop/maintain operational manuals, DSMB coordination/management, ensure timely data collection/reporting, etc.
• Document Management: Establish and maintain the Sponsor Trial Master File (TMF)

Data Management:

• Database development and ongoing maintenance activities
• Perform data management review/cleaning
• Ensure overall data completeness and quality/integrity
• Facilitate data reporting/archiving