Senior Central Monitor
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Job Description
Senior Central Monitor supporting centralized data, risk assessment, and remote site monitoring for ProPharma’s biotech, medical device, and pharmaceutical clients.
Responsibilities:
- Perform remote site monitoring and management activities for assigned projects in accordance with FDA and/or local regulations, ICH GCPs, ProPharma Group SOPs, and project plans
- Support study monitoring teams in implementing study strategies, initiatives, processes, and standards
- Support collection of data and report generation for recruitment planning, enrollment, drug supply status, site payment status, and other clinical trial tracking
- Support data risk assessments as assigned
- Support monitoring teams throughout the study, including communication with clinical site institutions as appropriate
- Support document collection, visit preparation, study data review, and central monitoring activities as assigned
- Develop or contribute to tools and processes that improve project efficiency
- Perform other duties as assigned
Requirements:
- Bachelor’s degree preferred; persons without a formal degree who have comparable depth and breadth of training and experience and meet job-specific criteria are eligible for consideration
- Minimum 3 years of experience in study coordination and in-house monitoring, or relevant work experience in the Biotechnology or Pharmaceutical industries or a relevant regulated environment
- Effective communication and interpersonal skills
- Ability to partner with cross-functional internal and external stakeholders
- Ability to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
- Ability to contribute to development of tools and processes that increase measured project efficiencies
- Proficiency with clinical trial execution systems, including Electronic Document Management Systems, Electronic Data Capture Systems, and Clinical Trial Management Systems
- Good understanding of general quality assurance concepts and practices
- Highly organized with strong attention to detail
- Working knowledge of Cluepoints RBQM System desired
- Long-haul COVID/Pulmonary experience desired
Benefits:
- Remote working support
- Hybrid working encouraged for new hires living within a reasonably short commute of a ProPharma office, as agreed with the manager
- Equal Opportunity Employer workplace committed to diversity, equity, and inclusion
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