Clinical Document & TMF Specialist

Reporting into the Sr. Manager/AD of Clinical Monitoring and Documentation, the Clinical Document and TMF Specialist is integral to the life cycle management of clinical documentation for Inozyme clinical studies, including oversight of documentation in the Trial Master Files (TMFs). 

Responsibilities

• Assist clinical study teams with the set up and maintenance of internal folder structures, including the QC, filing and maintenance of clinical documents
• Contribute to and verify the setup of TMFs and affiliated plans
• In collaboration with the clinical study teams, ensure the timely filing of documents in the TMF, performing quality checks as needed 
• Conduct TMF oversight activities in accordance with the TMF oversight plan, including but not limited to, quality checks and review of metrics to assess overall health of the TMF 
• Triage, troubleshoot and escalate issues to the Sr. Manager/AD of Clinical Monitoring and Documentation, as needed 
• Facilitate resolution of TMF questions with internal and external stakeholders
• Contribute to TMF inspection and inspection readiness activities 
• Facilitate the distribution of documents for review and/or signature, as needed
• Establish and maintain trackers to support the life cycle management of documents through execution  
• Contribute to the development of Standard Operating Procedures (SOPs)
• Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory requirements

Required Qualifications

• Associate’s/Bachelor’s Degree with at least 1+ year of TMF experience and document management or a minimum of 4 years of experience in clinical research, TMF / eTMF experience, and document management.
• Experience with ICH GCP e6 (R2) / GCP regulations, and DIA Reference module
• Previous TMF Oversight Responsibilities, preferred.
• Excellent verbal and written skills
• Attention to detail and quality are critical to success
• Ability to work collaboratively and independently
• Results-oriented individual who is highly motivated

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