• Provides input and support to Clinical Operations and Clinical Development teams through the course of studies• Organize meetings and produce agendas and minutes for internal and external teams• Review Essential Documents packages to initiate site activation and IP release• Organize and maintain files for both internal study teams and program Trial Master File• Develop patient-facing materials in accordance with ethics committee standards• Manage listings for clinical trial registries• Assist in the QC process for study-related documents and plans• Actively assist in the editing and approval of master, country, and site specific ICFs• Reconcile and track documents for study close-out procedures• Maintain study-specific CTMS records• Work closely with multiple CRO’s and external vendors

Supported Data Managers and Lead Data Managers in early phase clinical trials for a variety of therapeutic areas• Created weekly and monthly metrics reports using data exports from EDC• Reconciled discrepancies between central/local laboratory data and EDC data• Entered and Quality Controlled local laboratory ranges in accordance with study-specific conventions• Performed medical coding using WHODrug and MedDRA coding dictionaries• Authored Data Management instructional controlled documents for internal use by department• Prepared project specific correspondence for Study Coordinators, PI’s and CRA’s ; Tracked and filed documents to ensureaccuracy and completeness• QC’d documents and reports for client presentations to ensure accuracy• Performed edit check testing for EDC database openings• Ran SAS programs to generate client reports

• Oversaw daily operations of 250-seat, full service dining and beverage facility generating $3-4 million total annual sales• Supervised staff of 20-35 employees per shift, monitored guest satisfaction, product quality and overall operations• Collaborated with management to review employee performance, analyze operational costs, plan future projects• Coordinated daily, live entertainment program by networking with local musicians• Drafted Policies and Procedures documents for entertainment acts to ensure adherence to company image and policy• Analyzed hourly sales reports to optimize scheduling and labor costs• Prepared and submitted daily sales, labor and audit reports• Performed annual employee reviews