Clinical TMF Operations Administrator

COMPANY BACKGROUND

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 marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis).
We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

Akero Therapeutics is developing medicines that deliver transformational outcomes to patients with serious metabolic diseases. Our lead clinical program, Efruxifermin (EFX), is a treatment for non-alcoholic steatohepatitis (NASH), rapidly emerging as the leading cause of liver disease around the world. Efruxifermin is a novel long-acting fibroblast growth factor 21 (FGF21) agonist, with the potential to substantially improve the lives of patients with NASH, and other serious metabolic diseases.

We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

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 and also takes direction from the Sr Clinical Program Manager.

The position will interact with all areas of Clinical within Akero Therapeutics and Novo Nordisk.  The position interacts with team members at the IC through Vice President level.  The position requires experience interacting with senior level positions in each of these departments and a good understanding of how these peer teams operate, ideally through experience working within these teams (broad experience).

Externally, the position will engage with CROs and potentially with regulatory authorities.  For CROs it will be entry level through Sr Management level. For regulatory, the person needs to have the ability and experience to engage directly with auditors (FDA/GLOBAL). Once again emphasizing the need for significant experience.

Job Responsibilities

Clinical TMF Operations Management

• 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.

eTMF Health & Oversight

• 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.

Quality, Compliance & Inspection Readiness

• 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.

Operational Execution & Support

• 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.

Strategy, Process Improvement & Leadership

• 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.

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 (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.

 

The base compensation range for this position is $99,600 to $155,400. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.  

Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors.  

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

 

The job posting is anticipated to close on July 21, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at https://akerotx.com/job-opportunities.

 

EEO Statement:

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.