Emily Vella

Experience

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  Axiom Real-Time Metrics

  Aug 2015 - Jul 2021

  - Timeline and milestone management: Create timelines based on client milestones, ensure deliverables are provided to the client per agreed upon timelines.- eCRF design, configuration and validation: Design eCRF, implement eCRF, complete internal validation of the eCRF and applicable modules (including ePRO), review and discuss eCRF with client, lead a guided UAT session for the client upon request, create Test Scripts to guide client UAT, address client UAT feedback.- Document creation: Create Site materials such as CRF Completion Guidelines and Tips & Tools documents; create patient-facing materials such as ePRO User Guides and Setup Instructions.- Communicate with ePRO vendors to ensure validated questionnaires meet their requirements once implemented.- Work with the client to determine which reports and data listings would be most beneficial for their study, then design the report specifications and complete internal validation of the reports upon configuration.- Financial management: Create a budget and invoicing schedule based on the SOW, create estimates for out-of-scope work, invoice client per budget and approved estimates.- Cross-team collaboration: Work closely with the Data Management team to discuss study timelines and action items and ensure deliverables are provided per agreed upon timelines. Work with the Customer Care team as required to help resolve client / end-user concerns.- Delegate tasks to team members and track their progress via team meetings and the monday.com work management software.- Lead client teleconferences, review meeting materials such as Agendas, Minutes, and Action Items lists.- Support clients and end-users via email / phone.- Train clients to use certain modules.- Initiate Change Controls for new functionality requests and complete testing for those requests once configured.- Coach and develop Project Management team members.- Review and update SOPs. Show less - Timeline and milestone management: Ensure deliverables are provided to the client per agreed upon timelines.- eCRF design, configuration and validation: Design eCRF, implement eCRF, complete internal validation of the eCRF and applicable modules (including ePRO), review and discuss eCRF with client, lead a guided UAT session for the client upon request, create Test Scripts to guide client UAT, address client UAT feedback.- Document creation: Create Site materials such as CRF Completion Guidelines and Tips & Tools documents.- Design report specifications per client requirements and complete internal validation of the reports upon configuration.- Financial management: Create a budget and invoicing schedule based on the SOW, create estimates for out-of-scope work, invoice client per budget and approved estimates.- Cross-team collaboration: Work closely with the Data Management team to discuss study timelines and action items and ensure deliverables are provided per agreed upon timelines. Work with the Customer Care team as required to help resolve client / end-user concerns.- Lead client teleconferences, create meeting materials such as Agendas, Minutes, and Action Items lists.- Support clients and end-users via email / phone.- Initiate Change Controls for new functionality requests and complete testing for those requests once configured. Show less

  • Sr. Project Management Associate

    Jul 2018 - Jul 2021

  • Project Management Associate

    Aug 2015 - Jun 2018
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  Cloudbyz

  Jul 2021 - Oct 2023

  Project Manager

  - Timeline and milestone management: Create timelines based on client milestones, ensure deliverables are provided to clients per agreed upon timelines.- eCRF design, configuration, and validation: Design eCRF, implement eCRF, complete internal validation of the eCRF and applicable modules, review and discuss eCRF with client, lead a guided UAT session for the client upon request, address client UAT feedback.- Module management: Understand client’s requirements and translate them to the project team for configuration such as CTMS, eTMF, Patient Recruitment, EDC (including eCRF and ePRO). For ePRO, communicate with vendors to ensure that validated questionnaires are configured to their liking.- Project management report design: Work with the client to determine which reports would be most beneficial for their study, then design the report specifications and complete internal validation of the reports upon configuration.- Financial management: Create SOW and change orders if required for out-of-scope work.- Client communication: Email communication, lead client calls / teleconferences.- End-user training: Provide EDC and ePRO training for Site staff.- Work with the support team as required to help resolve client / end-user concerns.- Delegate tasks to team members.- Coach and develop Project Management Team members.- Review and update SOPs. Show less

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  Evinova

  Jan 2025 - now

  Digital Health Implementation Specialist