Laura DeVivo
Chicago,IL
Summary
Focused on applying strong research skills toward improving data management, organization and reporting. Solid background with pharmaceutical companies and learning new systems, processes and procedures quickly to maximize contributions. Highly collaborative and goal-oriented. Veteran SMA III effective at developing and maintaining systems keeping data collection efficient, accurate and secure. Enterprising and logical with detail-oriented and systematic nature. Ready to bring 20 years of experience to dynamic, growth-oriented position with IQVIA.
Overview
15
15
years of professional experience
Work History
Study Manager Associate (SMA) III
AbbVie
Lake County
11.2018 - Current
- Self-Designed role to fill gaps between the Clinical Study Leadership Team and the Product Study Team ensuring consistency across 3 Major Compounds creating standard procedures and training for safety reporting from vendors and other stakeholder functional areas where communications needed improvement
- Manges unity across multiple functional areas on behalf of CSL including, Regulatory, Clinical Trails Strategy, Global Medical Affairs, Finance, Quality, and Clinical Processes to ensure critical timelines are met
- Liaison between CSL and Product Study Team (PST) for 3 critical compounds (Humira over 40 studies, Skyrizi over 25 studies, and Rinvoq over 40 studies)
- SME and contributor for the Investigator Brochure (IB), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), Periodic Adverse Drug Experience Report (PADER)
- Liaisons between PST and Global Medical Affairs for non-interventional and investigator-initiated studies
- Streamlined processes and communication between groups resulting in Standard procedure for implanting guidance from PST for safety risk language
- Tracking PST response to ethics committees and agency response to safety risk language and Investigator Brochure across indications for consistent responses relieving PST from answering the same questions over and over
- Skyrizi’s main contact for adjudication and data monitoring committee (DMC) for both internal PST/Study Teams and external vendors for over 25 studies and approximately 4,500 subjects
- Defined the role of adjudication and data monitoring committee contact person, by creating, leading, and streamlining processes to capture safety events for the PST and statistics
- Received agreement within AbbVie’s Therapeutic Areas (TA) using the same adjudication vendor for agreement for standardized process procedures and communication between Vendor and TA Leads
- Initiates and ensures 2 Charters for Adjudication and 2 Charters DMC are being followed by vendor and committee members
- Leads monthly vendor calls to review and resolve any outstanding subject adverse events queries
- Investigate questions from Study Trial MD and Safety Team with vendor data and put in place a risk mitigation plan for the quality of the data
- Drives Team timelines with vendors ensuring database locks are met
- Utilized cross-functional collaboration and various reporting tools to track study milestones, analyze data, and optimize future improvements
- Elevates study team and vendor performance through comprehensive training, ensuring seamless alignment with study requirements and fostering a culture of excellence
- Managed, balance, and reduced costs for a 2.5-million-dollar budget for adjudication and DMC services ensuring timely payment to vendor and committee members
- SME for Skyrizi DMC and Adjudication audits and CAPA resolutions
- Leads audit responses for DMC and adjudication audits ensuring the 5 steps to root cause analysis approach are being used
- Received internal awards for participation in QA audits and CAPA resolutions
- Stakeholder for expertise in Reporting and Disclosure for all Therapeutic Areas for Investigator Brochure, Development Safety Update Report, Periodic Safety Report, and Periodic Adverse Drug Experience Report
- Systematically identified cross-functional stakeholders analyzing the needs and expectations for reporting and disclosure and developing and implementing process procedures for Clinical Study (CSL)Team
- Subject matter expert for Medical Writing as Clinical Study Leadership representative in DevU for reporting and disclosure questions from AbbVie Clinical
- Subject Matter Expert for content, distribution, and submission on behalf of CSL and other Functional Areas regarding IB, DSUR, PSUR, PADER, and other regulatory reporting
- Providing information and resources for the improvement of regulatory reporting
- Collaborator for PPS Safety, Medical Writing, and Process Improvement Teams, for discussions strategizing distribution of reports with evidence of release
- Created Job Aid for CSL offering fast, simple, and needed training and support resulting in improved process compliance
- Created training and templates to engage teams when working on reports.
SMA II and III
AbbVie
Lake County
04.2012 - 11.2018
- Supported and coordinated global clinical trials phases I- IV from start-up through close out
- Contributing to protocol, and informed consent creation, review of country regulations, managed vendors ensuring compliance with study protocol and agency regulations, resolving issues and mitigating risks by providing strategic solutions
- Experienced in study start up, maintenance and close-out procedures for global studies
- Managed CRO vendor to drive clinical timelines, mitigate and resolve issues with sites, ensure regulatory compliance
- Managed BioClinica vendor x-ray and MRI vendor, escalating unresolved issues upper management for F2F meeting resulting in Vendor CAPA to ensure compliance to their SOPs and ours
- Managed Quest Labs vendor for smooth and easy access for sites to systems
- Collaborated with the One Hits Data Science team to meticulously capture and track three critical training points throughout the study for each site, ensuring timely completion of investigator training and facilitating smooth subject visits
- Presented protocols at investigator meetings to achieve rapport with investigators, invite feedback on procedures, and mitigate any risks for delays in the activation of sites
- Mentored new SMAI and II for various Study Project Managers helping new hires to improve their knowledge and skillsets, helping them learn AbbVie culture, systems, and network to accomplish work and grow professionally.
Clinical Document Specialist (CDS)
03.2009 - 04.2012
- Oversaw the creation, control, and compliance of various documents, including SOPS and quality management records
- Ensured accurate record-keeping, regulatory compliance and supported audits to maintain high standards in documentation processes
- Centralized data and created work instructions to implement best practices, specific task clarity, and improved communication resulting in consistent outcomes on projects across therapeutic areas
- Proactively initiated innovative approaches, identified effective solutions to minimize risks and ensured non-compliance avoidance.
Payroll Analyst
Rush University Medical Center
- Oversaw payroll for over 5,000 employees.
Fund Accounting Management
Rush University Medical Center
- Managed fund accounting for over 700 funds.
Recruiter
Rush University Medical Center
- Conducted recruitment activities for subjects for multiple studies.
Research Coordinator
Rush University Medical Center
- Screened and ensured qualification of subjects for studies, developed internal clinical record files for subject visits and visit cover page to ensure all required data was collected, conducted subject visits adhering to protocol and good clinical practices, submitted sponsor related documents to internal ethics committee and prepared for sponsor visits ensuring compliance for data for sponsor.
Research Coordinator Manager
Rush University Medical Center
- Worked with Rush finance and study sponsor finance for budgeting, managed and mentored 12 direct reports providing training for growth and knowledge of studies, subjects screening, history, and follow-up.
Education
BS - Health Information Management
WGU
05.2024
Associate in applied sciences - Radiology Technology
Malcolm X College
12.2009
Skills
- Audit Management with a focus on Corrective and preventive actions (CAPA)
- Audit Management
- Data Organization
- SOP Development
- Compliance Monitoring
- SOP Compliance
- Troubleshooting
- Form Reviewing
Affiliations
- Volunteers in community fund raisers for Christmas without Cancer
- Writing
- Traveling
Accomplishments
- Agile and Accountable Award- Finalization of DMC Internal Systems Audit - 2023
- Clear and Courageous - Shining example - Facilitating adjudicated adverse event data resulting in vendor CAPA and resolutions- 2023
- Publications: 2007, Blood Pressure Monitor; A Comparison of Two Sphygmomanometers that may Replace the Traditional Mercury Column in the Healthcare Workplace
- Publications: 2000, Kidney International; The Val-L Study ACE Inhibitors or Angiotension Receptor Blockade: Impact on Potassium in Renal Failure
Timeline
Study Manager Associate (SMA) III
AbbVie
11.2018 - Current
SMA II and III
AbbVie
04.2012 - 11.2018
Clinical Document Specialist (CDS)
03.2009 - 04.2012
Payroll Analyst
Rush University Medical Center
Fund Accounting Management
Rush University Medical Center
Recruiter
Rush University Medical Center
Research Coordinator
Rush University Medical Center
Research Coordinator Manager
Rush University Medical Center
BS - Health Information Management
WGU
Associate in applied sciences - Radiology Technology
Malcolm X College
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