Experience

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  Baxter healthcare

  Jan 2006 - Jan 2010

  Project manager, clinical data management

  • Directed independent and team-based data management efforts for Renal Global Clinical Affairs, including vendor management, statistician and clinical monitoring collaboration meetings, plan documentation preparation, and buildout of data cleaning system capabilities.• Partnered with Baxter Nephrology’s renal division and served as CDM lead on 3 Phase IV studies involving home hemodialysis devices and solutions, and collaborated with clinical team on creation of a case report form.

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  Dsp clinical research

  Jan 2010 - Jan 2012

  Senior clinical data manager

  • Served as Clinical Data Management lead on 2 phase III clinical trials involving female health therapeutic areas; directed data management efforts and oversaw study deliverables, reporting, and communication with pharmaceutical sponsor clients.• Oversaw project management for series of phase I studies; reviewed invoices, responded to client inquiries, managed changes to scope and budget, and communicated project updates to clients.• Assisted executive leadership with implementation of an in-house data management department; implemented data management plan templates, external data specifications, electronic case report forms, medical coding/review guide, and data reconciliation and EDC user management processes. Show less

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  Biopharm systems

  Jan 2013 - Jan 2013

  Cdm consultant

  • Reviewed existing clinical trial data management study set up in Oracle Clinical (OC) and tested/documented study set up to ensure data was captured accurately for hematology, oncology, and transplantation therapeutic areas.• Edited mock data and reconciled with OC output to ensure validation and derivations performed to specifications.

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  Medidata solutions

  Dec 2013 - now

  • Delivers indirect leadership to a team of 3 onshore and offshore project managers overseeing client support; delivers guidance and training on processes, project plans, reporting, and product inquiries.• Manages 2 Global 500 client account relationships; participates in client governance structuring, serves as point of contact for any escalated issues, and oversees all client communications.• Directs large, complex projects and programs for Global 500 clients, including an enablement program for teaching teams trial configuration building and an electronic clinical outcome assessment (eCOA) implementation that provided study participants with new avenues for submitting data for regulatory approval.• Reviews client-specific processes, identifies improvement opportunities, and develops standard operating procedures for new project managers and offshore resources to effectively and consistently perform job responsibilities. Show less • Directed large, complex projects involving custom datasets, extracts, report building, and user acceptance testing; managed resources, created internal tickets, identified budget/timeline estimates, performed quality control testing, and ensured products/services were delivered on time and within budget.• Supported clients with technological implementations, including Rave Coder, a tool enabling coding of clinical trial raw data and iMedidata, a tool that coordinated client information sharing and increased enablement and efficiency.• Managed client implementation of risk-based monitoring, cloud admin, and Rave EDC, a tool to help increase testing validation and process efficiency; oversaw platform development efforts and implementation of SaaS solutions. Show less

  • Product Adoption Solution Lead

    Apr 2022 - now

  • Client Services Director

    Jan 2022 - Apr 2022

  • Engagement Director, Enterprise Professional Services

    Jan 2020 - Jan 2022

  • Senior Project Manager

    Dec 2013 - Jan 2020