Manager, Monitoring & Site Management
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Job Description
Clinical monitoring manager overseeing site compliance, staffing, and contractor delivery for Alimentiv. Supporting sponsors and researchers across clinical trial projects.
Responsibilities:
- Plan, manage, organize, evaluate, and/or report on daily delivery of the Clinical Monitoring unit
- Develop and improve policies and processes
- Oversee product quality, site monitoring, compliance monitoring, staff resource planning, and staff and contractor performance management
- Support and represent project and clinical monitoring teams with sponsors and researchers throughout the project life cycle
- Ensure team members and third-party providers deliver high-quality, timely services in accordance with corporate and industry best practices and regulatory requirements
- Identify, develop, plan, monitor, approve, and/or report on project-specific processes and services related to site selection, clinical monitoring, ICH-GCP compliance issue resolution, global project harmonization, SOP and QS document maintenance, site visits, and IT collaboration
- Represent and support Clinical Monitoring teams with internal partners and external sponsors to improve services, address concerns, and integrate technologies and processes
- Manage Clinical Monitoring team staffing, work allocation, resource planning, training, development, technology, process development, expenses, engagement, and performance
- Identify, procure, and manage Clinical Monitoring independent contractor services, including recruitment, contract negotiations, compliance, training, cost monitoring, and performance management
- Provide clinical, site, and compliance monitoring expertise and develop tools supporting project teams and business development from bidding through sponsor reporting
Requirements:
- College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred, or SoCRA and/or ACRP Certification/Designation)
- Minimum of 4–6 years related experience
- Substantial ongoing training
- Experience managing CRA staff
- Ability to provide training and/or mentorship to colleagues on a 1:1 basis or in meetings
- Ability to work in a remote global capacity
- Strong knowledge of regulations and guidelines pertaining to clinical monitoring and GCP
- Customer-service-oriented and solution-oriented approach
- Demonstrated leadership skills
- Strong verbal, written, and organizational skills
- Ability to handle multiple tasks and meet deadlines in a dynamic environment
Benefits:
- Bonus
- Home-based work / remote global capacity
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