Summary: The Sr. CPM is a key member of Clinical Operations and will closely partner with the Director of Clinical Operations.
- Will serve as the key operational contact for Akero studies, leading site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Set-up 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.
- Creates and reviews protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures.
- 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.
- As required, will directly manage clinical operations personnel.
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 6+ years of relevant experience and a BS or BA in a relevant scientific discipline or
- At least 6+ years of experience and an RN (2 or 3 year certificate)