[Hiring] Clinical TMF Operations Administrator @Akero Therapeutics

Role Description

The Clinical TMF Operations Administrator will contribute to the execution of the Phase 3 clinical development program for EFX. Key responsibilities include, but are not limited to:

• Clinical protocol development
• Medical monitoring
• Data analysis and reporting of results for regulatory submissions or scientific presentations and publications

Relationships:

• Reports to the Sr Dir, Clinical Program Management
• Takes direction from the Sr Clinical Program Manager
• Interacts with all areas of Clinical within Akero Therapeutics and Novo Nordisk
• Engages with CROs and potentially with regulatory authorities

Job Responsibilities

• Clinical TMF Operations Management:
  • 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 (QI) workflows
  • Govern Expected Document Lists (EDL), including completeness, accuracy, and reconciliation of document counts
  • Monitor compliance with TMF business processes and escalate risks or non-compliance as needed
  • Deliver scheduled and ad hoc TMF health metrics, analysis, and insights
• Quality, Compliance & Inspection Readiness:
  • Ensure TMF inspection readiness through ongoing quality oversight
  • Provide subject matter expertise (SME) for audits and inspections
  • Maintain current knowledge of regulatory requirements and industry best practices
• Operational Execution & Support:
  • Support TMF document processing, including filing oversight and troubleshooting
  • Participate in trial-specific and departmental meetings
  • Perform general operational and administrative activities to support assigned trials
• Strategy, Process Improvement & Leadership:
  • Contribute to TMF strategy, planning, and continuous improvement initiatives
  • Support Clinical Operations leadership on high-impact projects
  • Supervise TMF operations, proactively identify risks, and implement mitigation strategies

Qualifications

• A bachelor’s degree in a related discipline and 4+ years’ work experience, preferably in a relevant clinical research setting
• 2-3+ years’ experience in eTMF document management is an advantage
• Strong organizational/prioritization skills for the management of workload and attention to detail
• Strong experience collaborating with the DIA (CDISC) TMF Reference Model
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
• Experience leading or overseeing TMF operations
• Ability to influence stakeholders and drive accountability across teams
• Experience generating and interpreting TMF health metrics and analytics
• Demonstrated success in process improvement, SOP development, and TMF strategy implementation
• Excellent organizational and prioritization skills with strong attention to detail
• Proactive, solution-oriented mindset with ability to anticipate risks
• Strong communication skills, with the ability to present insights and recommendations

Requirements

• The base compensation range for this position is $99,600 to $155,400
• This position is also eligible for a company bonus based on individual and company performance

Benefits

• Long-term incentive compensation depending on the position's level
• Medical, dental, and vision coverage
• Life insurance and disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Tuition reimbursement program
• Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance
• Time off pursuant to its sick time policy, flexible vacation policy, and parental leave policy

Company Description

Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases.