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).

Qualifications:

• 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)