Akero Therapeutics logo
Akero Therapeutics

Restoring Balance. Renewing Life.

Clinical TMF Operations Administrator

Clinical OperationsClinical OperationsFull TimeRemoteSeniorTeam 11-50Since 2017H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

4 days ago

Salary

$99.6K - $155.4K / year

Seniority

Senior

Bachelor Degree4 yrs expEnglishGoogle Cloud Platform

Job Description

Clinical TMF Operations Administrator

Akero Therapeutics

• 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.

Job Requirements

  • 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

  • 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

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