Michele Andrush

Experience

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  WYETH PHARMACEUTICALS

  Jan 1992 - Jan 2003

  • Reviewed protocols and CRFs to assure functionality and compliance with standards• Assured system development tasks are accurately completed and performed a final review• Functioned as a departmental technical resource and assist in the development of new technical processes• Represent Clinical Data Management in multidisciplinary settings and maintain communications between staff in European and US sites• Editing and resolution of inconsistencies and errors in data collected during investigational drug research• Assured the quality completion of all work associated with assigned projects and reported project status routinely to appropriate personnel within Clinical Operations and CR&D• Generated and resolved Data Clarification Forms for assigned study sites through routine contact• Tracking data flow and monitoring of staff workload• Trained and mentored new employees in basic data management skills• Liaison between Wyeth project group and CRO Data Management Team• Assist with migration of databases to Oracle Clinical Show less • Performed with proficiency all clinical data handling functions• Generated and resolve Data Clarification Forms• Project Leader responsible for assuring the quality completion of all work associated with an assigned project and reporting project status routinely to appropriate personnel• Effectively organize, prioritize, and distribute work in order to produce an accurate database• Interact effectively with CR&D personnel to resolve data problems• Performed timely completion of new system development including editing specifications and system review Show less

  • Technical Advisor

    Jan 1997 - Jan 2003

  • Clinical Data Analyst

    Jan 1992 - Jan 1997
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  Cephalon

  Jan 2004 - Jan 2005

  Clinical Data Analyst

  • Reviewed Case report forms• Generated edit specifications and data review guidelines, edited queries, and resolved data issues• Coordinated and interact with Clinical staff to resolve data issues

• 

  THERAKOS

  Jul 2005 - Feb 2008

  Data Management Specialist

  • Assisted with the development and review of CRFs and associated documents, protocols, and system setup• Liaison between Contract Research organizations to ensure database setup and timely delivery of databases and other trial results• Worked closely with colleagues in order to relay clarifications to CROs• Provided input in the company development of processes and infrastructure concerning data management• Review and edit department SOPs

• 

  AstraZeneca

  Feb 2008 - Apr 2009

  Sr. Study Delivery Operations Specialist

  • Assisted study teams with study and data management activities utilizing RAVE• Validated and monitored web-based data capture data flow, issues and resolved queries, tracked data review, reported to team progress and trends• Reviewed validation work by team members to ensure all issues are resolved in RAVE• Established and maintained key interactions with customers (internal/external) and clinical departments to ensure the quality of SD deliverables

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  Xogene

  Oct 2010 - Aug 2023

  Project Manager & Senior CT Transparency Specialist
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  ExecuPharm

  Oct 2011 - May 2012

  Remediation Lead

  • Reviewed Study Records in the Client Registry and provision reports and communication to Study Teams on all missing or required data points • Reviewed study records in the Client registry and performs relational QC as required between/amongst documents as needed• Identified potentially incorrect and missing data points, and reviewed the total registry record with study team members• Provided Data Entry Specialist with the required information to make necessary entries/corrections to each study in the Client Registry Show less

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  Certara

  Aug 2023 - now

  Associate Director, Disclosure Services