Director of Information Systems overseeing the design and optimization of enterprise data and applications at Blackstone Industrial. Leading a team to deliver scalable decision - support tools across multiple business domains.
About the role
- Associate Director managing Trial Master File and SOP development for clinical programs at Generate Biomedicines, a leader in Generative Biology™.
Responsibilities
- Responsible for the strategic leadership, operational oversight, and quality governance of the Trial Master File (TMF) process
- Serve as the subject matter expert (SME) for all TMF-related activities
- Oversee the eTMF system and all related processes
- Lead the creation and continuous improvement of Clinical Operations Standard Operating Procedures (SOPs)
Requirements
- 7+ years of relevant TMF experience, SOP development, and/or operations leadership
- In depth knowledge of relevant regulations and GCP
- Deep understanding of ICH-GCP, 21 CFR Part 11, TMF Reference Model, and clinical trial lifecycle
- Proficient knowledge of CDISC Reference Model
- Strong working knowledge of clinical study documentation
- Proficiency in Veeva Vault eTMF and Microsoft Office Suite
- Extensive experience working with eTMF systems and CRO oversight
- BA/BS required; life sciences or related field preferred
Benefits
- Competitive benefits package
- Annual bonus
- Equity compensation
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