Clinical TMF Operations Administrator

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Akero Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Akero Therapeutics is a company pioneering novel therapies to transform the lives of people living with serious metabolic diseases. Their flagship program, Efruxifermin (EFX), is aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) and is currently undergoing multiple clinical trials. Akero is committed to advancing medicine in the field of metabolic diseases and has a strong focus on research, development, and clinical studies.

📋 Description

• 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

• 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