Deanna Welytok

Experience

• 

  Dart Communications

  Jul 1997 - Aug 2006

  • Business Manager

    Aug 1999 - Aug 2006

  • Sales Manager

    Jul 1997 - Aug 1999
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  GPS Pharmaceutical Services, LLC

  Aug 2006 - May 2010

  • Developed budgets and financial forecasts to predict the need for new contracts and contract bidding.• Implemented Accounts Payable/Accounts Receivable and expense control procedures.• Prepared timely and accurate month-end closings and financial reports.• Researched account transactions, demonstrating a keen ability to recognize and resolve discrepancies. • Performed bank, credit card and account reconciliations.• Prepared cash receipts, disbursements, billing, invoicing, expense reporting and bank deposits. • Ensured optimization of tax write-offs and compliance with small business tax law; liaison with Accountant. Show less • Involved in the selection, recruitment, set-up and maintenance of study sites• Responsible for regulatory document collection and review and administrative activities associated with study start-up to ensure compliance.• Reviewed, clarified, organized and processed case report forms, regulatory documents and other materials as defined within study timelines. • Developed computerized tracking applications based on study needs using computer software programs and entered study specific data into Clinical Trial Management systems.• Participated in study related training, meetings and teleconferences.• Completed time and expense reports. Show less

  • General Business Manager

    Jul 2008 - May 2010

  • Clinical Research Associate I

    Dec 2006 - Jul 2008

  • Project Coordinator

    Aug 2006 - Dec 2006
• 

  I3 Research

  May 2010 - May 2011

  Independent Consultant, CRA

  • Provided site support and management for electronic CRF data entry, query response and resolution.• Managed assigned sites by performing regular telephone contact, ensuring site compliance, and performing remote regulatory binder review while adhering to GCP/ICH Guidelines, SOPs, and all other applicable regulatory requirements.• Primary contact for the support and training of investigational sites.• Ensured that sites have proper regulatory documentation, IRB approval, and updated informed consent documentation.• Reported to i3 Research project team, client, and site personnel any findings noted during telephone contact, or site visits and significant issues to appropriate personnel.• Enforced Serious Adverse Event compliance and respond to all SAE queries from data management team and/or the safety department.• Managed time, finances and client deliverables in accordance with the contract, while ensuring financial profitability and performed administrative functions (e.g., tracking expense reports, time and attendance). Show less

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  InVentiv Health

  May 2011 - Apr 2014

  Project Research Manager

  • Manage the study timeline through interim and final data lock by establishing mini milestones, and communicate potential impact/updates to the study team.• Conduct study team meetings and facilitate cross-functional meetings to meet timelines and milestones.• Proactively identify and communicate risks that may affect the critical path and timelines• Review and evaluate clinical trial safety and lab data to ensure patient safety.• Develop trackers and use forecasting tools (budget, timeline projections, enrollment) to track study status.• Manage interface with third party vendors, functions and affiliates at the trial level.• Coordinate the development of contingency plans and risk mitigation at the trial level.• Anticipate, understand and address compliance and GCP issues identified during the course of the trial.• Develop presentations and trackers to present study status updates to management.• Facilitate networking across the study team and promote effective teamwork and problem solving.• Develop trial level documents such as monitoring plans, informed consent documents, site and patient facing tools and study newsletters.• Monitor trial budget, track expenses and conduct change management as needed.• Answer and/or direct trial protocol/technical questions from sites and third party vendors.• Ensure that all study documents and project files are maintained according to policies and procedures.• Proactively ensure documentation is complete for protocol violations, investigator/ERB information, and study decisions and other elements that are required for the clinical study report or submission. • Ensure Computer Trial Management System (CTMS) is accurate and track projected milestone dates to defined metrics. Show less

• 

  Eli Lilly and Company

  Jan 2014 - now

  • Associate Director IWRS Design and Development

    Jul 2022 - now

  • Clinical Data Associate

    Apr 2014 - Jul 2022

  • Clinical Trial Manager

    Jan 2014 - Apr 2014