Associate Director, Clinical Operations job in Bethesda at Technical Resources International
Technical Resources International

Job Info

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Responsibilities:

At least 12 years of experience in clinical research and operations management supporting Phase I-IV clinical trials at pharmaceutical, biotechnology, and/ or contract research organizations, with line management in addition to project management oversight responsibility for multiple functional areas within one or more complex drug development programs with demonstrated ability to manage deliverables within budget and to well-defined timelines. Experience in clinical operations and clinical study management (study design, study start-up, essential regulatory/ TMF documentation review/ collection, and site monitoring activities) with an understanding and working knowledge of regulatory (FDA requirements, GCPs/ICH guidelines), data management/ analysis, and scientific/ technical writing processes and requirements, to primarily support government contracts with the National Institutes of Health in multiple therapeutic areas, i.e., infectious disease (vaccines and treatments), oncology, and drug abuse.

Recommended Skills

• Ich Guidelines
• Technical Writings
• Presentations
• Research
• Leadership
• Documentation

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