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| | Click here or scroll down to respond to this candidateCandidate's Name MBA, BSc.Bernardsville, NJ Street Address Mobile: PHONE NUMBER AVAILABLEEMAIL AVAILABLEhttps://LINKEDIN LINK AVAILABLERx/Clinical PROJECT MANAGER:My Project Management foundation is 13 years in Rx/OTC Pharmaceuticals, with experience in Rx Field Sales, Rx/OTC Market Research, Clinical Research Operations, CGT Clinical Supply Production and Rx-related Project Management. I leverage my knowledge as a client-facing, strategic project liaison. My skills are in collaboration and influential Project/Team Management. My projects cover a wide range in Clinical Trial Automation, PPI/Process Optimization; Cell and Gene Therapy; Clinical Trial Supply and Logistics categories. I employ deep experience in Immunology/Oncology, Strategic Analysis, Servant-Style Leadership, Collaboration, PPI/Kaizen optimization and Active Risk Management.EXPERIENCE:Contingent Project Manager, Bristol Myers Squibb/All Source PPS: Lawrenceville, NJ 11/23 PresentI was recruited as a Project Manager by BMS/All Source PPS to support Business Intelligence & Analysis (BI&A) Clinical Trial Recruitment and RWD-Guided Clinical Trial optimization projects. I manage a $4.2 Million portfolio of Innovation projects, with vendors like Oracle Life Sciences, Deep 6 AI and TriNetX. My high-quality output support BMS Leadership Team initiatives and clinical trial optimization efforts, focused on Immunology & Hematology therapeutic areas. My contract renewal options were truncated, due to a major BMS reorganization in April 2024.Sr. Program Manager, Cell/Gene Therapy, Catalent Pharma Solutions: Baltimore, MD 7/22 12/22Recruited to Catalent CGT to manage $12MM program in AAV Gene Therapy Phase II Clinical Supply production.Maintained cGMP software training and HIPAA Compliance requirements using LIMS and proprietary software. Tracked projects and completed Tech Transfer data packages with QC, QA, and clients, such as Gyroscope TX.Delivered overdue Tech Transfer data packages to clients, despite massive CMC/QA department turnover. Stabilized program financials and GANTT timetables to accommodate 2024 PDUFA submission timetable.Executed two simultaneous Ophthalmic BDS fills for Phase II Clinical Trial Supply before resigning when I became aware of financial viability concerns (-28% YOY revenues). Catalent was dismantled and assets sold in 2023.Project Manager III, Bio Services, Thermo Fisher Bio Services: Rockville, MD 5/21 6/22Recruited to Fisher Bio Services manage a $5+ MM portfolio of Commercial/DoD/Academic Cold-Chain Logistics projects. These biorepository projects included strategic Dept of Defense vaccine storage and transport logistic projects, as the strategic vaccines moved through DoD development/distribution process to allies worldwide.Optimized stockpile allocation and disposal programs for Fort Detrick strategic vaccines program under COVID.Managed clinical trial supply for Astra Zeneca's Acalabrutinib (CLL) and NIDDK Diabetes Longitudinal Trial clinical supplies. Led/executed diagnostic GCP kitting assembly projects for research and commercial clients.Managed support staff and maintained CGMP Compliance software in Track Wise LIMS and Documentum.Digital Project Manager/Content Creator, Quora.com: New York, NY 3/20 5/21During the COVID Pandemic, I wrote health/wellness content while isolated at home, which drew attention from isolated site visitors to Quora.com Management. My following grew in parallel to pandemic isolation.Invited to become a Content Panelist for Quora.com, based on reviews of my contributed content. I created responses to Community queries that generated over 1,400,000 discrete visitor views on Quora.com since 2020.In December 2020, invited to join Quora.com as a paid content contributor but gave it up to comply with Thermo Fisher Employment Policy.Candidate's Name , MBA, BSc. (Page 2 of 2)EXPERIENCE:Associate Clinical Project Manager, Carelon Research, Inc.: Wilmington, DE 9/18 8/19Recruited to administer Late-Phase Trial Operations for a Phase IV COPD study, with 350+ investigator sites and study team of nine. To increase client satisfaction, I spearheaded CTMS record clean-up, as well as worked with Project Manager to optimize the most productive PI recruitment efforts, Site Initiation as well as optimized PI/Patient payment schemes and Site Productivity/Close-Out Criteria.An Agile Project Manager mentored me while I administered and optimized Patient Recruitment Schemes to achieve client-mandated patient recruitment optimization and PI Site Sign-Up goals.Within an AGILE Project Management framework, I maintained eTMF upkeep; utilized EDC, CRF and CTMS software systems; site investigator agreements, ICF development, Investigator selection.Principal/Project Manager, Exuberant Energy NY, LLC: New York, NY 2/12 8/18During 2016-17, I became as a Revenue Cycle Manager Account Manager, promoting offshore remote medical billing and billing accrual solutions locally, leveraging CRM software in the Medical Clinic sales cycle. I joined Carelon Research in 2018 to begin a transition into clinical research Project Management. I also contributed analysis to an alternative-energy coalition in Westchester County, NYConceived and executed benchmark analysis of worldwide Factor Xa Clinical Research, to describe/predict new FDA indications for the Xarelto JV (Bayer/J&J) during 2014-16.In 2012-14, adopted and promoted a novel Attitudinal Patient Segmentation Model, to help perfect longitudinal patient outcomes and post-discharge expenditures, leveraging Consumer Packaged Goods promotional lift modeling to optimize and describe 30-day post discharge relapses in chronic disease categories.EARLY CAREER SUMMARY: Sr. Market Strategist, SOURCE Data NDC Health Newtown, PA Sr. Research Manager, Advertising Publicis Rx/OTC Division New York, NY Sr. Marketing Research Analyst Wyeth International Philadelphia, PA Sr. Rx Field Representative, HIV+ Janssen / J&J Manhattan, NY (#1 of 10)EDUCATION: Columbia University Graduate School of Business New York, NYMaster of Business Administration Boston University College of Communications Boston, MABachelor of Science, Communications ManagementCERTIFICATIONS: Project Management Institute Newtown Square, PACAPM (Certified Associate in Project Management) (Expired 1/2024)PMP (Project Management Professional) (In Progress 2024)SOFTWARE:Microsoft Office 365 (Excel, Word, PowerPoint, Teams, Outlook, Visio, SharePoint, Project, Yammer.)LIMS: Track Wise; Compliance Wire, Documentum; Smart Sheet; JIRA; ICH-9/HIPAA/cGMP/GLPRWE/RWD; Medline; EDC/EMR; CTMS; eTMF, Agile/PMP studies in progress via Udemy.com. |