Trial Master File

Therapy area

Experience (yrs)



16 - 20



Uniquely qualified with leadership, communication, and organizational skills. Experienced in staff and study management, within multiple therapeutic areas including oncology, neurology, psychiatry, infectious disease, pain management, ophthalmology, gastroenterology and Trial Master File coordination and process improvement. Proficient in ensuring the effective execution of simultaneous projects without compromising quality, timeliness or utility. An expert at consensus management and building upon the differences of the project management, monitoring, and clinical teams. Extensive qualifications in the following competencies: Trial Master File (TMF) Review/Remediation, Regulatory Audit Preparation, Project Management and Assessment, Strategic Planning, Mentoring & Personnel Development, Budget Management, IRB Communications, Vendor Relations, Contract Negotiations & Closing, Site Selection & Oversight, Study Management & Implementation, Customer Service, Database Design & Management, Quality Control Design & Implementation.

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