Ilona Panis

Experience

• 

  GB

  Sept 2002 - Oct 2004

  Department Manager

  Creating local promotionsMeetings with the group and with all managersAdministration in WinstoreFollowing up the OrdersCorrecting flaws in ordersMaking orders, time schedules, meetings, reportsCalculating the marges weekly and monthlyQuality checkings of HACCPOther duties that are necessary to create a perfect view for the customer (levelling, codes, filling the merchandise etc)Checking pricesEditing new products

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  Biomedical Systems

  Oct 2004 - Jan 2015

  Effectively manage the activities of Application Development in a manner that ensures all timeframes and targets are met with the highest quality to the sponsor’s satisfaction.Coordinate the planning, implementing and delivering of Application Development projects in accordance with signed contracts between BMS and sponsors; manage projects in a timely manner in adherence with BMS SOPs and appropriate regulations.Write and review the study specific protocols (i.e. Data Load Specifications) and other associated documentation.Liaison with the operational department’s Clinical Project Manager and other company resources as required by each study/project.Provide support to the programmers/data managers for all study related activities.Assist with testing of various codes developed by programmers.Review Application Development’s performance against established metrics.Provide study/project specific training to assigned resources prior to study start-up as necessary.Knowledgeable of other BMS department SOPs, processes and guidelines related to Application Development.Act as the primary contact for studies or special projects as requested by Management.Interact and collaborate with other project team members to ensure consistency and data quality.Identify performance gaps, report to department management and follow-up resolution of these gaps.Assist with orientation and training of new employees as needed.Mentor less experienced clinical data coordinators in project start-up activities.Report to the manager of Application Development.Other duties as deemed necessary by Management. Show less Prime Contact to CRO/SponsorCreating Load Specifications, Validation Protocols, Test Reports for specific Study ProtocolDevelop and document Procedures for Application DevelopmentValidate study and application programsCommunicate programming needs and problem solving with various departments and sponsorsSupport programmers of Data Management departmentFollowing Up on e-mail traffic, reconciliation listingsProcedure of Data Base Lock confirmationArchivingAccountancy of Data SubmissionsReport issues to the Data Manager or Project ManagerLeading Sponsor Meetings to discuss the Data Transfers ProtocolsOther duties as deemed necessary to ensure high qualities service Show less Visually verify all manually entered information on clinical data;Visually verify all cardiologist’s interpretations to clinical data where appropriate;Review clinical data for consistence of information;Document any necessary changes necessary to clinical data;Notify appropriate department of any necessary updates needed to clinical data;Visually verify all entered values in the supplemental databases;Assist in performing the final QA check of pharmaceutical data submissions;Knowledgeable of Quality Assurance SOP’s, computer network, and timeline importance;Other duties as deemed necessary to ensure high quality service. Show less

  • Senior Clinical Data Coordinator

    Jan 2012 - Jan 2015

  • Clinical Data Coordinator

    Feb 2007 - Jan 2012

  • QA Operator

    Oct 2004 - Feb 2007
• 

  Kelly Services

  Feb 2015 - Dec 2016

  Lead Global Clinical Data Manager (Neuroscience, ID&V in ED) @ Janssen Pharmaceutica

  Lead Global Data Manager at Janssen Pharmaceutica contracted by Kelly Outsourcing and Consulting Group • Accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations • Liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s) • Ensures Inspection Readiness of all data management deliverables and ensures adequate archiving of data management documentation• Member of Study Management Team and Clinical Working Group(s) and leads the trial subteam(s)/workstream(s) for data management deliverables (e.g., eCRF design, Database Lock)• Participates in or leads a non-trial related project within Integrated Data Services (IDS) or cross functionally Show less

• 

  The Janssen Pharmaceutical Companies of Johnson & Johnson

  Jan 2017 - Apr 2021

  Senior Global Data Manager

  • Accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations • Liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s) • Ensures Inspection Readiness of all data management deliverables and ensures adequate archiving of data management documentation• Member of Study Management Team and Clinical Working Group(s) and leads the trial subteam(s)/workstream(s) for data management deliverables (e.g., eCRF design, Database Lock)• Participates in or leads a non-trial related project within IDAR or cross functionally Show less

• 

  Johnson & Johnson Innovative Medicine

  Apr 2021 - now

  • Accountable for project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations• Liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s)• Ensures Inspection Readiness of all data management deliverables and ensures adequate archiving of data management documentation• Member of Study Management Team and Clinical Working Group(s) and leading trial subteam(s)/workstream(s) for data management deliverables (e.g., eCRF design, Database Lock)• Mentoring new hires on Data Management activities. Show less

  • Manager, Global Data Manager

    Jul 2024 - now

  • Principal Global Data Manager

    Oct 2023 - Jul 2024

  • Global Data Manager Specialist

    Apr 2021 - Oct 2023