Clinical Trial Manager
Akero Therapeutics
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $96,760 - $178,840 per year
About the role
- Assist Clinical Program Manager with set-up of regional CRO and other vendors as required, including liaising with Global CRO to ensure site training and timely initiation.
- Day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to Clinical Program Manager.
- Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track.
- 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.
- 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.
Requirements
- At least 4+ years of relevant experience and a BS or BA in a relevant scientific discipline OR
- At least 4+ years of relevant experience and an RN (2- or 3-year certificate)
- Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent
- Experience as the regional lead for Europe, United States, and/or India.
- 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 initiatives under general supervision
- High energy level, personal productivity, creativity and commitment.
- Team-player desiring to work in a fast-moving, dynamic start-up environment.
Benefits
- medical, dental and vision coverage
- life insurance
- disability insurance
- 401(k) savings plan
- flexible spending accounts
- employee assistance program
- tuition reimbursement program
- voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
- time off pursuant to its sick time policy
- flexible vacation policy
- parental leave policy
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial experiencesite selectionstudy implementationdata discrepancy resolutionprotocol reviewregulatory document reviewclinical study report preparationinvestigator brochure compilationmonitoring plan knowledgeSOP compliance
Soft Skills
attention to detailverbal communicationwritten communicationinterpersonal skillspresentation skillscreativitypersonal productivityteam collaborationproblem-solvingstrategic initiative participation
Certifications
BS or BA in a relevant scientific disciplineRN certificate