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Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines.
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Serves as study lead and primary contact for sponsors.
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Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory.
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Generates and presents frequent study status updates and reports to sponsor.
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Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates.
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Supervises and trains Associate CPMs and provides ongoing support and high-level guidance to CPMs.
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Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.
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Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones.
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Ensures accuracy of reports and material work product.
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Provides monthly billing information to finance team.
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Presents at project meetings such as investigator meetings and new client meetings.
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Updates management accurately and regularly through frequent communication.
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Identifies issues and develops problem-solving strategies to ensure study timelines are met.
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Manages subject accrual, retention, and compliance.
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Assists in TMF management and manages TMF reviews as needed.
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Prepares for and participates in third-party audits and FDA inspections.
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Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs.
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Participates in internal, client/sponsor, scientific, and other meetings as required.
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Performs additional duties as assigned.
