Clinical Trials Manager-Consultant – Akero Therapeutics

1-Year Employee Growth Rate | 2-Year Employee Growth Rate | LinkedIn | $0 Venture Funding

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Job Summary:

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.

Job Responsibilities:

• 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.

Qualifications

• 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).

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