North Arlington, NJ
QUALITY ASSURANCE SYSTEMS ENHANCER PROJECT DIRECTION
A driving force in changing last luster processes and instituting modern practices that revitalize staff and organizations to reach well beyond their perceived capabilities in capturing the once unattainable. Quality Assurance activist introducing practices that align with regulatory standards centralizing and elevating business practices. Influential and trusted confidant to senior leadership team and colleagues. Bilingual professional fluent in English and Spanish.
Microsoft Applications (Word, Excel, PowerPoint, Outlook, MS Projects), PleaseReview, STAR, PeopleSoft (Revenue, Backlog, Billing and Invoicing), Inform (eDC), RAVE, ARAVO, ARIBA, AGORA, Trial Master System, International Contract Database, Totality, ICH/GCP, AMISYS, Unisys-NJ, Medical Terminology, CTMS, OTIS-NJ Lookup, WordPerfect, Peachtree Accounting, Lotus
Notes, DataBase, SPSS, Visio, Intranet/Internet.
Speak, read/write fluent English and Spanish.
Novartis Pharmaceuticals, Inc. East Hanover, NJ
QA Operations Specialist, GxP, Dev QMS Governance & Integration 6/2012 - 2/2018
Support STAR registration in DQT Cross-Functional Governing roles: LFAR, LFRC, STGB, PQMB, PIC, TCR_Rep, SME workshops and Lead SME
Provide operational support to GDD Team for all related activities related to Procedure & Training Governance Board (PTGB); agendas, meeting minutes, follow-up actions, tracking
Maintain project and trackers for SOP and Training Factory Development, which
include times and scheduling workshops with Global Leads, SOP Compliance
Managers and PTGB Members.
Assist with ongoing operations of PTGB; serve as the point person with Board members and Subject Matter Experts (SME).
Manage changes to project scope, ensuring that all impacts and changes were approved and appropriately communicated to stakeholders and review boards (PTGB, PQMB, and PIC).
Maintain the STGB SharePoint site, folder structure and content.
Generate reports of project status and managing confidential documents via SharePoint site.
Manage multiple calendars, including scheduling and arranging SOP/Training Factory workshops.
Prepare and update routine documents and create general correspondence to team, as necessary.
Assist in Leading and taking minutes, including distribution and follow-up with team via email/Sharepoint.
Provide back-up support on activities on Quality Systems and Standards, including generating reports from training database, assignment of applications, and QC of documents
Conduct routine cross functional training of internal trackers and programs.
Work closely with cross-functional teams to identify and consolidate processes.
Support the management of risk assessment and prioritize all regulatory based SOP and Training requests governed by scope of activities PTGB.
Janssen Scientific Medical Affairs, Johnson & Johnson Raritan, NJ
Project Coordinator, Internal Medicine/Medical Affairs 9/2010 - 3/2012
Worked closely with the Director of Clinical Project Specialist to develop tracking mechanisms for Internal Medicine division.
Lead initiative to reduce multiple tracking systems and cohesively maintained into one database.
Forecasted and drove key clinical milestones for multiple projects in Cardiovascular and Metabolics.
Created and implemented Cardiovascular/Metabolics/Analgesics internal contract tracker.
Initiated all Medical Affairs contract and request proposals (Research, Consulting,
Service and Pre-Clinical) via the International Contract Database.
Initiated, maintained, and closed all contract records by capturing value transfers of HCPs in Totality system.
Point person to research and provide clinical articles and publications to Chameleon.
Key contact to research and submit NDA/IND Annual Reports Call of Information to the FDA.
Requestor for establishing finance accounts to HCPs/vendors through ARAVO system.
Managed and tracked consultant’s financial invoices and follow-up for payments accordingly.
Responsible for maintaining and executing the clinical activities related to Advisory Boards, Steering Committees, Epidemiology, Pre-Clinical Studies, Outcome Studies, Analysis, Market Research, Survey/Questionnaire, Consulting, CDA (Confidentiality Agreement) and REMS (Risk Evaluation and Mitigation Strategy)
Adhered to company’s CREDO and confidentiality policies
Quintiles Transnational Corp. Parsippany, NJ
Senior Project Coordinator, Oncology Clinical Development 8/2006 - 2/2010
Coordinated all information and communications for multiple Phase I-IV study trials in therapeutic backgrounds in Oncology, CNS, Biotech and Infectious Disease and Internal Medicine.
Maintained project plans, timelines, scheduling meetings, agendas and presented project progress.
Set-up and maintained project documentation files, records and application files.
Developed and maintained internal databases, tracking systems and project plans for all appropriate trials.
Prepared and distributed tracking of project finances and scope of work reports in PeopleSoft, including revenue, back log, billing, and invoicing.
Accountable for preparing and distributing analytical status of activities to include Site Selection, Patient Recruitment, Medical Monitoring, SAE/AE, Queries, and Regulatory Affairs.
Conducted site review with CRA to monitor and ensure protocol compliance.
Participated in investigative meetings around the US.
Facilitated and lead project team meetings and responsible for building effective project teams.
Transcribed and recorded minutes, notes and actions at assigned meetings, distributed and followed-up accordingly.
Coordinated with other project support staff within and across the Global Project Management Unit to identify and consolidate support processes.
AMERIGROUP, New Jersey Edison, NJ
Managed Healthcare Company 9/1996 - 8/2006
Administrative Data Specialist, Quality Management
Directly reported to the Vice President of Quality Management in handling all administrative functions, including correspondence, calendar scheduling, travel arrangements, accounts payable and expense reports.
Participated in processes, coordination, including quality improvement studies for audit reporting to the State:
EPSDT, Prenatal Care and Pregnancy Outcomes, Lead, Asthma, Member/Provider Complaint & Grievance
and Annual Assessment of HMO Operations
Performed data collection of medical records for quarterly State reports and audits.
Accurately maintained database for Plan’s focus studies and quality improvement activities.
Supported all the preparation for committee meetings and follow-ups as directed:
Medical Advisory Committee, Pharmacy & Therapeutic Committee (quarterly) and Quality Management Committee (monthly)
Maintained database into AMISYS Medical System: authorizations, medical services, and records review.
Centralized Appeals Database–maintaining database for all claims and medical appeals for the entire plan.
Ensured all compliance standards by perpetuating and consistently practicing policies and procedures.
Upsala College, East Orange, NJ
Bachelor of Arts, Psychology and Latin American Studies
Lambda Theta Alpha Latin Sorority, Inc., Founder, Omicron Chapter