Akero Therapeutics (, 2 Yr Employee Growth Rate)
Akero Therapeutics 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 NASH, a disease for which there are currently no marketed therapies.
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 seeking a Clinical Trial Manager, consultant to be a key member of Clinical Operations and will closely partner with the Sr. Clinical Program Manager. The contract period is 12 months, with possibility of extension or full-time hire.
- 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.
- Assist Senior Clinical Program Manager with set-up of study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
- Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track.
- 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.
- 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/ trial master files.
- Performs administrative duties in a timely manner as assigned.
- At least 3+ years of relevant clinical research experience in the pharmaceutical or healthcare industry and a BS or BA in a relevant scientific discipline or, RN
Technical Requirements and Skills:
- Excellent attention to detail
- Strong communication skills: verbal, written, interpersonal and presentation skills are required
- Must be familiar with routine medical/scientific terminology
- Strong proficiency in MS, Word, PowerPoint, and Excel
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
- High energy level, personal productivity, creativity and commitment.
- Team-player desiring to work in a fast-moving, dynamic start-up environment.
- This position is remote, but may require domestic travel as required (valid travel documents must be obtainable).