Mike Gavazzi
Manager, Clinical Trials Technology & Supplies at Invivyd- Claim this Profile
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Bio
Credentials
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GCP ICH Refresher
CITI ProgramMay, 2023- Nov, 2024
Experience
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Invivyd
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United States
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Biotechnology Research
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1 - 100 Employee
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Manager, Clinical Trials Technology & Supplies
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Apr 2023 - Present
• Develop study and department trackers for optimal metrics and milestones reporting. • Engage with TechOps to ensure adequate forecasting of clinical study supplies and inventory levels. • Performs unblinded reviews of monitoring reports. • Manage protocol registration for the clinicaltrials.gov registry including initial submissions and updates and drive planning with appropriate functions for results posting. • Manage IRT implementation and design specifications as well as UAT… Show more • Develop study and department trackers for optimal metrics and milestones reporting. • Engage with TechOps to ensure adequate forecasting of clinical study supplies and inventory levels. • Performs unblinded reviews of monitoring reports. • Manage protocol registration for the clinicaltrials.gov registry including initial submissions and updates and drive planning with appropriate functions for results posting. • Manage IRT implementation and design specifications as well as UAT testing • Monitor and manage IRT threshold levels of clinical supplies • Forecast and monitor ancillary supplies and equipment inventory for a given clinical study • Develop and deploy study Newsletter content • Review TMF Index and Expected Documents List (EDL) for completeness and accuracy • Perform periodic QC of study TMFs • Develop and deploy Study Team Training Matrix of study plans and manuals • Construct and manage Clinical Operations and study SharePoint sites • Perform selection and qualification of new and existing vendors • Develop, review and execute SOP generation and updates
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Sr. Clinical Trial Associate
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Mar 2021 - Apr 2023
• Key participant in the start-up, implementation, management, and close-out of clinical trials, including preparation of clinical study protocols, case report forms, informed consent documents, clinical study reports, Investigational New Drug (IND) Applications, and BLAs/NDAs. - Provides support for clinical trials, including generation of study materials, tracking of study milestones and metrics, and QC of study documents, such as clinical protocols. - May be responsible for… Show more • Key participant in the start-up, implementation, management, and close-out of clinical trials, including preparation of clinical study protocols, case report forms, informed consent documents, clinical study reports, Investigational New Drug (IND) Applications, and BLAs/NDAs. - Provides support for clinical trials, including generation of study materials, tracking of study milestones and metrics, and QC of study documents, such as clinical protocols. - May be responsible for limited focus within a clinical trial including study team management or management of specific vendors (e.g., central laboratories). - Tracking and management of study supplies and samples; overseeing procurement and fulfilment of orders, etc. • Drafts Study Informed Consent Form templates and independently manages the review and approval of site-specific Informed Consent Forms. • Develops presentation materials for and may present at Investigator Meetings and prepares presentations for and performs Site Initiation Visits. • Assists with development and review of study manuals (monitoring plan, pharmacy instructions, etc.). • Reviews monitoring reports generated by CROs or contract CRAs. • Participates in the development and review of Standard Operating Procedures. • Participates in vendor evaluation in conjunction with experienced internal personnel. • Assists the Clinical Operations Lead in oversight of study conduct. • May assist in the site audit process and coordinates the audit responses to ensure conformance to industry and company standards. • Perform UAT and specification design of IRT systems • Manage the operational execution of clinical supply strategies • Manage protocol registration for the clinicaltrials.gov registry including initial submissions and updates and drive planning with appropriate functions for results posting.
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Insmed Incorporated
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United States
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Biotechnology Research
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500 - 600 Employee
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Sr. Clinical Trial Associate
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Mar 2020 - Feb 2021
• Provides support and assist with all phases of clinical study activities (feasibility, start-up, maintenance, and close-out) • Create and distribute of study materials, including essential documents, presentations, and reports • Development of work instructions and process improvement • Review CRO/Vendor SOPs for applicability and gap analysis to support clinical trials • Manage vendors to ensure tasks and timelines are on track and within budget • Review, process and track… Show more • Provides support and assist with all phases of clinical study activities (feasibility, start-up, maintenance, and close-out) • Create and distribute of study materials, including essential documents, presentations, and reports • Development of work instructions and process improvement • Review CRO/Vendor SOPs for applicability and gap analysis to support clinical trials • Manage vendors to ensure tasks and timelines are on track and within budget • Review, process and track invoices related to study agreements through iProcure • Responsible for reviewing clinical trial agreements and manage site budget negotiations • Works with cross-functional team to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines and government regulations • Track site selection during PSV, SIV, and monitor IMV visits. Facilitate any queries raised during the visits for resolution • Participates in study team and vendor meetings. Schedule meetings and draft meeting minutes/distribute final minutes, as needed. • Review Regulatory Compliance Review (RCR) for greenlight of IP release to sites • User Acceptance Testing (UAT) for EDC, eConsent and ePROs • Responsible for the collection of essential documents and maintenance of both paper and electronic Trial Master File. • Performs periodic Trial Master File quality control check through the course of study as defined by the study team, per ICH GCP requirements. Show less • Provides support and assist with all phases of clinical study activities (feasibility, start-up, maintenance, and close-out) • Create and distribute of study materials, including essential documents, presentations, and reports • Development of work instructions and process improvement • Review CRO/Vendor SOPs for applicability and gap analysis to support clinical trials • Manage vendors to ensure tasks and timelines are on track and within budget • Review, process and track… Show more • Provides support and assist with all phases of clinical study activities (feasibility, start-up, maintenance, and close-out) • Create and distribute of study materials, including essential documents, presentations, and reports • Development of work instructions and process improvement • Review CRO/Vendor SOPs for applicability and gap analysis to support clinical trials • Manage vendors to ensure tasks and timelines are on track and within budget • Review, process and track invoices related to study agreements through iProcure • Responsible for reviewing clinical trial agreements and manage site budget negotiations • Works with cross-functional team to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines and government regulations • Track site selection during PSV, SIV, and monitor IMV visits. Facilitate any queries raised during the visits for resolution • Participates in study team and vendor meetings. Schedule meetings and draft meeting minutes/distribute final minutes, as needed. • Review Regulatory Compliance Review (RCR) for greenlight of IP release to sites • User Acceptance Testing (UAT) for EDC, eConsent and ePROs • Responsible for the collection of essential documents and maintenance of both paper and electronic Trial Master File. • Performs periodic Trial Master File quality control check through the course of study as defined by the study team, per ICH GCP requirements. Show less
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Amicus Therapeutics
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United States
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Biotechnology Research
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300 - 400 Employee
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Clinical Trial Associate, Gene Therapy
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Mar 2018 - Mar 2020
• Monitor and track patient visits using visit calculators to ensure patient stay within protocol visit windows • Manage and track site feasibility, PSVs and SIVs • Develop/ update Informed Consent Form templates • Assist in the organization of Investigator Meetings • Works closely with data management assuring timely completion and submission of Electronic Case Report Forms (eCRFs) • Support Clinical Project Manager/Associate Director with meetings, including preparation of… Show more • Monitor and track patient visits using visit calculators to ensure patient stay within protocol visit windows • Manage and track site feasibility, PSVs and SIVs • Develop/ update Informed Consent Form templates • Assist in the organization of Investigator Meetings • Works closely with data management assuring timely completion and submission of Electronic Case Report Forms (eCRFs) • Support Clinical Project Manager/Associate Director with meetings, including preparation of agendas and minutes and tracking action items • Distribute trial-related materials to study sites such as ancillary supplies and equipment • Support preparation and subsequent distribution of newsletters • Create and maintain the Trial Master File and electronic workspace (SharePoint) for each study and the program. Ensure that all essential study documents are tracked and filed in a timely manner • Review study files/TMF periodically for accuracy and completeness • Review site regulatory and essential documents to approve initial drug shipment • Co-monitoring at site visits with assigned CRA • Tracked, reviewed and finalized monitoring visit reports • Processing/ submitting Confidentiality Disclosure Agreements and Clinical Trial Agreements (CTAs) through NextDocs • Assist with site budget negotiations as well as tracking budgets and CTAs • Submit and track vendor contracts/SOWs and invoices to ensure study stays within scope and budget Show less • Monitor and track patient visits using visit calculators to ensure patient stay within protocol visit windows • Manage and track site feasibility, PSVs and SIVs • Develop/ update Informed Consent Form templates • Assist in the organization of Investigator Meetings • Works closely with data management assuring timely completion and submission of Electronic Case Report Forms (eCRFs) • Support Clinical Project Manager/Associate Director with meetings, including preparation of… Show more • Monitor and track patient visits using visit calculators to ensure patient stay within protocol visit windows • Manage and track site feasibility, PSVs and SIVs • Develop/ update Informed Consent Form templates • Assist in the organization of Investigator Meetings • Works closely with data management assuring timely completion and submission of Electronic Case Report Forms (eCRFs) • Support Clinical Project Manager/Associate Director with meetings, including preparation of agendas and minutes and tracking action items • Distribute trial-related materials to study sites such as ancillary supplies and equipment • Support preparation and subsequent distribution of newsletters • Create and maintain the Trial Master File and electronic workspace (SharePoint) for each study and the program. Ensure that all essential study documents are tracked and filed in a timely manner • Review study files/TMF periodically for accuracy and completeness • Review site regulatory and essential documents to approve initial drug shipment • Co-monitoring at site visits with assigned CRA • Tracked, reviewed and finalized monitoring visit reports • Processing/ submitting Confidentiality Disclosure Agreements and Clinical Trial Agreements (CTAs) through NextDocs • Assist with site budget negotiations as well as tracking budgets and CTAs • Submit and track vendor contracts/SOWs and invoices to ensure study stays within scope and budget Show less
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Allergan
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Pharmaceutical Manufacturing
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700 & Above Employee
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TMF Compliance Associate
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Feb 2017 - Mar 2018
• Work with CTA to generate a customized TMF Reference Model and the TMF Management Plan for each study • Pull TMF Quality Review Summary Report from FirstDoc and provide to each functional area with assistance in performing their quality review of the TMF, reminding the team of the timeline and key milestones • Collaborate with TMF Management Associate (TMA) on any outstanding queries still in the Submission Portal before TMF closure • Discuss close out process with CTA including any… Show more • Work with CTA to generate a customized TMF Reference Model and the TMF Management Plan for each study • Pull TMF Quality Review Summary Report from FirstDoc and provide to each functional area with assistance in performing their quality review of the TMF, reminding the team of the timeline and key milestones • Collaborate with TMF Management Associate (TMA) on any outstanding queries still in the Submission Portal before TMF closure • Discuss close out process with CTA including any back logs or any missing information related to the TMF • Prepare TMF Close Out Authorization Form once all TMF documents have been collected and filed • Redesigned and manage content on the department SharePoint site, providing guidance and direction to the study team to file and house critical documents in the TMF • Contribute to TMF quality assessments including planning and preparation, execution, reporting of results, and assisting study teams with remediation and corrective actions, in order to prepare for inspection readiness activities of the TMF • Assess any acquired TMFs/eTMFs for any potential risks and perform migration processes of the acquired TMF • Provide support to study start-up by collecting, uploading, verifying information, and filing into TMF/eTMF • Pull reports from the Medidata CTMS system Show less • Work with CTA to generate a customized TMF Reference Model and the TMF Management Plan for each study • Pull TMF Quality Review Summary Report from FirstDoc and provide to each functional area with assistance in performing their quality review of the TMF, reminding the team of the timeline and key milestones • Collaborate with TMF Management Associate (TMA) on any outstanding queries still in the Submission Portal before TMF closure • Discuss close out process with CTA including any… Show more • Work with CTA to generate a customized TMF Reference Model and the TMF Management Plan for each study • Pull TMF Quality Review Summary Report from FirstDoc and provide to each functional area with assistance in performing their quality review of the TMF, reminding the team of the timeline and key milestones • Collaborate with TMF Management Associate (TMA) on any outstanding queries still in the Submission Portal before TMF closure • Discuss close out process with CTA including any back logs or any missing information related to the TMF • Prepare TMF Close Out Authorization Form once all TMF documents have been collected and filed • Redesigned and manage content on the department SharePoint site, providing guidance and direction to the study team to file and house critical documents in the TMF • Contribute to TMF quality assessments including planning and preparation, execution, reporting of results, and assisting study teams with remediation and corrective actions, in order to prepare for inspection readiness activities of the TMF • Assess any acquired TMFs/eTMFs for any potential risks and perform migration processes of the acquired TMF • Provide support to study start-up by collecting, uploading, verifying information, and filing into TMF/eTMF • Pull reports from the Medidata CTMS system Show less
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LifeCell, An Acelity Company
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United States
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Biotechnology Research
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200 - 300 Employee
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Clinical Operations Specialist (Acquired by Allergan December 20, 2016)
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Jul 2016 - Feb 2017
• Engineering Change Order (ECO) Champion for all Clinical Operations SOP revisions. Assist with annual document review and gap assessments. • Contributes to the harmonization of templates, procedures and work instructions globally within Clinical Affairs • Create, maintain, audit and archive Trial Master Files for company-sponsored studies • Manage SharePoint sites for all clinical studies electronic documents and aligns all study folders to harmonize with the DIA Reference Model •… Show more • Engineering Change Order (ECO) Champion for all Clinical Operations SOP revisions. Assist with annual document review and gap assessments. • Contributes to the harmonization of templates, procedures and work instructions globally within Clinical Affairs • Create, maintain, audit and archive Trial Master Files for company-sponsored studies • Manage SharePoint sites for all clinical studies electronic documents and aligns all study folders to harmonize with the DIA Reference Model • Support the CPM with start-up and closeout activities • Update and maintain Heartbeat Profiler for key stakeholders • Generate potential site information from investigator database as well as distributes site feasibility questionnaires to potential Principal Investigators (PI) Show less • Engineering Change Order (ECO) Champion for all Clinical Operations SOP revisions. Assist with annual document review and gap assessments. • Contributes to the harmonization of templates, procedures and work instructions globally within Clinical Affairs • Create, maintain, audit and archive Trial Master Files for company-sponsored studies • Manage SharePoint sites for all clinical studies electronic documents and aligns all study folders to harmonize with the DIA Reference Model •… Show more • Engineering Change Order (ECO) Champion for all Clinical Operations SOP revisions. Assist with annual document review and gap assessments. • Contributes to the harmonization of templates, procedures and work instructions globally within Clinical Affairs • Create, maintain, audit and archive Trial Master Files for company-sponsored studies • Manage SharePoint sites for all clinical studies electronic documents and aligns all study folders to harmonize with the DIA Reference Model • Support the CPM with start-up and closeout activities • Update and maintain Heartbeat Profiler for key stakeholders • Generate potential site information from investigator database as well as distributes site feasibility questionnaires to potential Principal Investigators (PI) Show less
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PTC Therapeutics, Inc.
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Biotechnology Research
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700 & Above Employee
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Clinical Trial Associate
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Nov 2015 - Jul 2016
• Responsible for the collection and QC of all clinical trial documentation • Maintain and monitor the eTMF and paper TMF for all studies for completeness and accuracy throughout the trials • Developed and maintained departmental Work Instructions (WI) and Standard Operating Procedures (SOPs) • Prepare all inactive studies for long-term archival • Publish and update all clinical trial information on ClinicalTrials.gov • Conduct monthly internal audits on all assigned clinical… Show more • Responsible for the collection and QC of all clinical trial documentation • Maintain and monitor the eTMF and paper TMF for all studies for completeness and accuracy throughout the trials • Developed and maintained departmental Work Instructions (WI) and Standard Operating Procedures (SOPs) • Prepare all inactive studies for long-term archival • Publish and update all clinical trial information on ClinicalTrials.gov • Conduct monthly internal audits on all assigned clinical trials • Prepare study for start-up and closeout process • Participate in mock inspections for TMF documents • Entitlement Coordinator for IMPACT CTMS access • Regulatory Compliance Review (RCR) Greenlight forms for IP shipment • Tracking and recording invoices received from clinical trial vendors • Maintain and update budget and study trackers to assigned trials for project managers Show less • Responsible for the collection and QC of all clinical trial documentation • Maintain and monitor the eTMF and paper TMF for all studies for completeness and accuracy throughout the trials • Developed and maintained departmental Work Instructions (WI) and Standard Operating Procedures (SOPs) • Prepare all inactive studies for long-term archival • Publish and update all clinical trial information on ClinicalTrials.gov • Conduct monthly internal audits on all assigned clinical… Show more • Responsible for the collection and QC of all clinical trial documentation • Maintain and monitor the eTMF and paper TMF for all studies for completeness and accuracy throughout the trials • Developed and maintained departmental Work Instructions (WI) and Standard Operating Procedures (SOPs) • Prepare all inactive studies for long-term archival • Publish and update all clinical trial information on ClinicalTrials.gov • Conduct monthly internal audits on all assigned clinical trials • Prepare study for start-up and closeout process • Participate in mock inspections for TMF documents • Entitlement Coordinator for IMPACT CTMS access • Regulatory Compliance Review (RCR) Greenlight forms for IP shipment • Tracking and recording invoices received from clinical trial vendors • Maintain and update budget and study trackers to assigned trials for project managers Show less
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Clinical Trial Project Associate
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Jun 2015 - Nov 2015
• Track Protocol Amendments and signature pages in ACTIVATE and STARS • Construct business reports, data extracts, and tools to improve and maintain CTMS data quality and operations • Maintain RegDoc, eTMF, and CDA mailboxes for new document submissions • Construct process improvements to data quality and workflows • Responsible for the upkeep of CDA updates and approvals • Upload all executed CDA’s into SharePoint • Support ClinAdmin data entry and maintenance of… Show more • Track Protocol Amendments and signature pages in ACTIVATE and STARS • Construct business reports, data extracts, and tools to improve and maintain CTMS data quality and operations • Maintain RegDoc, eTMF, and CDA mailboxes for new document submissions • Construct process improvements to data quality and workflows • Responsible for the upkeep of CDA updates and approvals • Upload all executed CDA’s into SharePoint • Support ClinAdmin data entry and maintenance of country, site and patient visit level data • Review, scan and upload IRB and ICF approvals into CREDI • Maintain the data tracking reports in SharePoint Show less • Track Protocol Amendments and signature pages in ACTIVATE and STARS • Construct business reports, data extracts, and tools to improve and maintain CTMS data quality and operations • Maintain RegDoc, eTMF, and CDA mailboxes for new document submissions • Construct process improvements to data quality and workflows • Responsible for the upkeep of CDA updates and approvals • Upload all executed CDA’s into SharePoint • Support ClinAdmin data entry and maintenance of… Show more • Track Protocol Amendments and signature pages in ACTIVATE and STARS • Construct business reports, data extracts, and tools to improve and maintain CTMS data quality and operations • Maintain RegDoc, eTMF, and CDA mailboxes for new document submissions • Construct process improvements to data quality and workflows • Responsible for the upkeep of CDA updates and approvals • Upload all executed CDA’s into SharePoint • Support ClinAdmin data entry and maintenance of country, site and patient visit level data • Review, scan and upload IRB and ICF approvals into CREDI • Maintain the data tracking reports in SharePoint Show less
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TransPerfect
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United States
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Translation and Localization
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700 & Above Employee
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Clinical Document Specialist
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Jun 2014 - Jun 2015
• Responsible for Trial Master File (TMF) quality for sponsor and CRO studies • Assist in audits of client TMFs as well as internal TMF audits • Prepare, process, and track paper and electronic documents received as per project guidelines in a timely manner • Ensure documents are scanned, imported, coded, and indexed into the eTMF and reviewed for quality and completeness • Archive all paper files and maintain an ongoing inventory list of all received files as per… Show more • Responsible for Trial Master File (TMF) quality for sponsor and CRO studies • Assist in audits of client TMFs as well as internal TMF audits • Prepare, process, and track paper and electronic documents received as per project guidelines in a timely manner • Ensure documents are scanned, imported, coded, and indexed into the eTMF and reviewed for quality and completeness • Archive all paper files and maintain an ongoing inventory list of all received files as per guidelines • Plan and perform periodical quality checks of eTMF and the paper TMF files to identify any filing issues experienced by the Clinical Trial Teams to ensure that both eTMF and paper TMF files meet internal and external quality standards • Assist in writing and editing SOPs to keep current with industry changes on TMF management, quality and archival • Conduct training team members as well as other TransPerfect Life Sciences Production teams on essential documents and regulatory requirements • Responsible for submission and inspection readiness of the TMF • Client facing to provide feedback, comments, and demos of Trial Interactive web-based archiving system Show less • Responsible for Trial Master File (TMF) quality for sponsor and CRO studies • Assist in audits of client TMFs as well as internal TMF audits • Prepare, process, and track paper and electronic documents received as per project guidelines in a timely manner • Ensure documents are scanned, imported, coded, and indexed into the eTMF and reviewed for quality and completeness • Archive all paper files and maintain an ongoing inventory list of all received files as per… Show more • Responsible for Trial Master File (TMF) quality for sponsor and CRO studies • Assist in audits of client TMFs as well as internal TMF audits • Prepare, process, and track paper and electronic documents received as per project guidelines in a timely manner • Ensure documents are scanned, imported, coded, and indexed into the eTMF and reviewed for quality and completeness • Archive all paper files and maintain an ongoing inventory list of all received files as per guidelines • Plan and perform periodical quality checks of eTMF and the paper TMF files to identify any filing issues experienced by the Clinical Trial Teams to ensure that both eTMF and paper TMF files meet internal and external quality standards • Assist in writing and editing SOPs to keep current with industry changes on TMF management, quality and archival • Conduct training team members as well as other TransPerfect Life Sciences Production teams on essential documents and regulatory requirements • Responsible for submission and inspection readiness of the TMF • Client facing to provide feedback, comments, and demos of Trial Interactive web-based archiving system Show less
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Celgene
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Clinical Document Specialist
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Dec 2013 - May 2014
• Review, timestamp, track and maintain all clinical documents using transmittal forms. • Prepare, reconcile, and process of transmittal form packages including resolving issues with submission of documents/ transmittal’s • Scan, index, quality check, and process clinical documents for completion • Provide transmittal and processing assistance to internal and external customers • File paper and electronic study documentation in file room and in electronic file system • Monitor… Show more • Review, timestamp, track and maintain all clinical documents using transmittal forms. • Prepare, reconcile, and process of transmittal form packages including resolving issues with submission of documents/ transmittal’s • Scan, index, quality check, and process clinical documents for completion • Provide transmittal and processing assistance to internal and external customers • File paper and electronic study documentation in file room and in electronic file system • Monitor documents in the Trial Master File (TMF) database in preparation for onsite and offsite archiving • Prepare inactive documents to archive for long-term storage Show less • Review, timestamp, track and maintain all clinical documents using transmittal forms. • Prepare, reconcile, and process of transmittal form packages including resolving issues with submission of documents/ transmittal’s • Scan, index, quality check, and process clinical documents for completion • Provide transmittal and processing assistance to internal and external customers • File paper and electronic study documentation in file room and in electronic file system • Monitor… Show more • Review, timestamp, track and maintain all clinical documents using transmittal forms. • Prepare, reconcile, and process of transmittal form packages including resolving issues with submission of documents/ transmittal’s • Scan, index, quality check, and process clinical documents for completion • Provide transmittal and processing assistance to internal and external customers • File paper and electronic study documentation in file room and in electronic file system • Monitor documents in the Trial Master File (TMF) database in preparation for onsite and offsite archiving • Prepare inactive documents to archive for long-term storage Show less
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Ortho Clinical Diagnostics
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United States
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Medical Device
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700 & Above Employee
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Validation Records Coordinator
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Jan 2012 - Nov 2013
• Responsible for managing all validation records from the site, including coordination and scanning of the validation documents with outside contractor, ensuring completeness of associated forms, and cross-referencing the electronic record with the validation database • Coordinate efforts throughout the site for the retrieval and reconciliation of validation records for review • Maintained and updated virtual records in network system • Import and export vital validation records to… Show more • Responsible for managing all validation records from the site, including coordination and scanning of the validation documents with outside contractor, ensuring completeness of associated forms, and cross-referencing the electronic record with the validation database • Coordinate efforts throughout the site for the retrieval and reconciliation of validation records for review • Maintained and updated virtual records in network system • Import and export vital validation records to offsite storage • Developed and constructed SOPs • Updated the validation database to reflect the current status of records • Partnered with validation group to close out and archive aged and current validations • Trained new employees and directed workload to drive process improvements within group • Partnered with management to create new process for the archiving and retention of records • Assisted in the retrieval of validations records for internal audits to ensure proper compliance for the company’s virtual records Show less • Responsible for managing all validation records from the site, including coordination and scanning of the validation documents with outside contractor, ensuring completeness of associated forms, and cross-referencing the electronic record with the validation database • Coordinate efforts throughout the site for the retrieval and reconciliation of validation records for review • Maintained and updated virtual records in network system • Import and export vital validation records to… Show more • Responsible for managing all validation records from the site, including coordination and scanning of the validation documents with outside contractor, ensuring completeness of associated forms, and cross-referencing the electronic record with the validation database • Coordinate efforts throughout the site for the retrieval and reconciliation of validation records for review • Maintained and updated virtual records in network system • Import and export vital validation records to offsite storage • Developed and constructed SOPs • Updated the validation database to reflect the current status of records • Partnered with validation group to close out and archive aged and current validations • Trained new employees and directed workload to drive process improvements within group • Partnered with management to create new process for the archiving and retention of records • Assisted in the retrieval of validations records for internal audits to ensure proper compliance for the company’s virtual records Show less
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Education
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2013 - 2016
DeVry University
Bachelor of Science (BS), Technical Management -
2009 - 2012
Raritan Valley Community College
Associate of Arts (AA), Criminal Justice
Community
