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Manage interdisciplinary clincical research projects, as Project Manager, leading the clinical team to ensure on time, on budget performance
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Supervise, train, and mentor Clinical Research staff
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Approve investigator study budgets and contracts
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Review and develop protocols
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Review and approve Case Reports Forms (CRFs)
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Plan, coordinate, and present at Investigators Meetings
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Participate in proposal meetings with potential clients
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Review Serious Adverse Event (SAE) reports
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Review and approve monthly client invoices
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Prepare project management reports for clients, project personnel, and internal management
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Review and approve monitoring trip reports
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Review Tables and Listings generated from study data
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Author Clinical Study Reports
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Train CRAs on monitoring, internal procedures, and query resolution
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Mentor Senior CRAs on project management procedures and policies
Job Qualifications:
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Bachelor’s degrees required; MS, MPH, PharmaD, PhD, or other advanced life science degree preferred.
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Five years of experience in clinical research, data management, or regulatory affairs, with at least 2 years of experience in the monitoring and management of clinical research project
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Ability and willingness to travel up to 20% of the time
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Excellent written and oral communication skill
