Akero Therapeutics

Clinical Research

• Assist Clinical Program Manager with set-up of regional CRO and other vendors as required, including liaising with Global CRO to ensure site training and timely initiation.
• Day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to Clinical Program Manager.
• Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track.
• Under supervision may serve as the key operational contact for Akero studies aiding in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
• Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
• Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
• Review of trip reports generated by CRO CRAs.
• Maintains study timelines.
• Coordinates review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies.
• Provides regular study updates to the appropriate internal stakeholders.
• Maintains internal Clinical Operations databases and document repositories.
• Performs administrative duties in a timely manner as assigned.

Clinical Trial Manager

Director

• Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution
• Serve as Medical Monitor for assigned clinical trials
• Support/manage preparation of materials for trial-related clinical committees
• Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities
• Contribute to the strategic planning, authoring, and critical review of scientific data disclosures
• Develop professional relationships with external clinical opinion leaders, investigators, and consultants
• Contribute to engagement with external stakeholders
• Function as an independent member of the team and represent clinical development at internal cross-functional or external meetings
• Other duties related to clinical development as assigned

Director, Clinical Development

• Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution
• Support medical monitoring activities for ongoing clinical trials.
• Support/manage preparation of materials for trial-related clinical committees such as Data Monitoring Committees, Adjucation Committees, etc.
• Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities and ethics committee/IRBs as required (e.g., Protocols, CSRs, IB, clinical briefing documents).
• Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications).
• Co-ordinate aggregate report preparation (e.g., DSURs, PSUSARs, ASR), and safety management plans (SMPs) in collaboration with external vendors
• Contribute to engagement with external stakeholders such as vendors, thought leaders or other groups as needed including being the primary liaison with assigned individuals or groups.
• Function as an independent member of the team and represent clinical research at internal cross-functional or external meetings.
• Other duties related to clinical development of EFX as assigned.

Clinical Trial Manager

Director, Clinical Development

Principal Clinical Scientist – Clinical Development