Akero Therapeutics

Clinical Research

• Assist the Clinical Program Manager with regional CRO and vendor setup
• Liaise with Global CRO to ensure site training and timely initiation with the EMEA CTM
• Oversee day-to-day CRO and trial-site contacts and identify potential EMEA site issues
• Ensure timely completion of deliverables, issue resolution, escalation, and communication to the Clinical Program Manager
• Lead EMEA regional regulatory submission strategies and package reviews
• Identify operational challenges and provide solutions to keep study execution on track
• Support site selection, study implementation, and ongoing site coordination in the EMEA region
• Perform accompanied site visits with CRO CRAs and review regulatory documents for compliance
• Assist with review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts, clinical study reports, and investigator brochures
• Review CRO CRA trip reports
• Maintain study timelines
• Coordinate data-listing reviews and interim/final clinical study reports, including resolving data discrepancies
• Provide regular study updates to internal stakeholders
• Maintain and review Clinical Operations databases and document repositories, including the study TMF
• Perform assigned administrative duties
• Mentor junior team members and contribute to operational process improvements

Senior Clinical Trial Manager