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Job Responsibilities:
- Lead TMF activities for assigned trials across start-up, maintenance, close-out, and archive phases.
- Oversee implementation and maintenance of processes for cataloging, filing, retrieval, storage, preservation, and protection of TMF records.
eTMF Health & Oversight:
- Manage eTMF health by overseeing Quality Issue workflows and ensuring timely remediation.
- Govern Expected Document Lists and monitor compliance with TMF business processes.
Quality, Compliance & Inspection Readiness:
- Ensure TMF inspection readiness through ongoing quality oversight and ad hoc QC reviews.
- Provide subject matter expertise for audits and inspections, including preparation and remediation.
Akero Therapeutics
Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases such as MASH. They are part of Novo Nordisk and foster a collaborative culture with diverse skill sets.