Clinical TMF Operations Administrator

Akero Therapeutics

Clinical TMF Operations Administrator contributing to Phase 3 clinical development program for Efruxifermin at Akero Therapeutics. Leading TMF operations and ensuring compliance and quality oversight.

Posted 7/14/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $99,600 - $155,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in TMF activities, including eTMF document management, compliance with regulatory requirements, and quality oversight. Proven ability to lead cross-functional collaboration, implement process improvements, and deliver actionable insights for clinical trial teams.

Highest-signal resume keywords

ETMF Document ManagementTMF Reference ModelFDA RegulationsGCPProcess Improvement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

TMF ActivitiesQuality Issue WorkflowsDocument ManagementTMF Health MetricsSOP DevelopmentRegulatory ComplianceData AnalysisRisk ManagementDocument Filing OversightTMF Strategy Implementation

Soft Skills

Organizational SkillsAttention to DetailCollaborationCommunicationProactive Mindset

Industry Keywords

Clinical ResearchClinical Trial TeamsCROsDIAICH Guidelines

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead TMF activities for assigned trials across start-up, maintenance, close-out, and archive phases, ensuring consistent communication with Clinical Trial Teams (CTT) and CRO partners.
Oversee implementation and maintenance of processes for cataloging, filing, retrieval, storage, preservation, and protection of TMF records (electronic and paper) and CTMS outputs.
Manage eTMF health by overseeing Quality Issue (QI) workflows, ensuring timely remediation of QC/QR findings, including closing or reassigning QIs as appropriate.
Govern Expected Document Lists (EDL), including completeness, accuracy, and reconciliation of document counts in collaboration with CTT and CRO teams.
Monitor compliance with TMF business processes and escalate risks or non-compliance to Clinical Operations and Quality leadership as needed.
Deliver scheduled and ad hoc TMF health metrics, analysis, and insights to support trial teams and leadership decision-making.
Ensure TMF inspection readiness through ongoing quality oversight, including ad hoc QC reviews of uploaded documents and maintenance of filing/naming conventions aligned with the TMF Reference Model.
Provide subject matter expertise (SME) for audits and inspections, including preparation, support, and remediation activities.
Maintain current knowledge of regulatory requirements, TMF Reference Model standards, and industry best practices.
Support TMF document processing, including filing oversight, troubleshooting, and responding to TMF-related inquiries.
Participate in trial-specific and departmental meetings, providing TMF expertise and status updates.
Perform general operational and administrative activities to support assigned trials.
Contribute to TMF strategy, planning, and continuous improvement initiatives, including development of processes, tools, and training for TMF stakeholders.
Support Clinical Operations leadership on high-impact projects and organizational initiatives.
Supervise TMF operations, proactively identify risks, anticipate challenges, and implement mitigation strategies to ensure delivery of team and project goals.

Requirements

What you’ll need

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 (in a specialized team or as a member of a clinical trial team) 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, including cross-functional collaboration with Clinical Trial Teams, CROs, and vendors.
Ability to influence stakeholders, escalate risks appropriately, and drive accountability across teams.
Experience generating and interpreting TMF health metrics and analytics to inform decision-making and improve performance.
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 and implement mitigation strategies.
Strong communication skills, with the ability to present insights and recommendations to both operational teams and leadership.

Benefits

Comp & perks

medical, dental and vision coverage
life insurance
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
sick time policy
flexible vacation policy
parental leave policy