Summary: The Clinical Trial Manager (CTM) is a key member of Clinical Operations and will closely partner with the Director of Clinical Operations.
- Under supervision may serve as the key operational contact for Akero studies, providing assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Assist Director of Clinical Operations with set-up of central labs and 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. 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.
Technical Requirements & Skills
- Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent
- Excellent attention to detail, verbal, written, interpersonal and presentation skills are required
- Must be familiar with routine medical/scientific terminology
- Must be familiar with Word, PowerPoint, and Excel
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
- Must be able to participate in departmental or interdepartmental strategic initiative under general supervision
- High energy level, personal productivity, creativity and commitment.
- Team-player comfortable in fast-moving, dynamic environments.
- This position is located in South San Francisco, California and may require domestic or international travel as required (valid travel documents must be obtainable).
- At least 3+ years of relevant experience and a BS or BA in a relevant scientific discipline or
- At least 3+ years of experience and an RN (2- or 3-year certificate)