Seasoned Technical Project Manager

Thomas C. Calloway MBA

Milford, DE *****

Mobile: 732-***-**** *************@*****.***

https://www.linkedin.com/in/ThomasCCallowayNYC

SEASONED PROJECT MANAGER IN REGULATED INDUSTRIES:

My Project Management foundation is 7 years managing Technical Projects, leveraging HIPAA, ISO9001/15378 GMP and GCP/GMP methodologies. I leverage both analytical skills and client-facing, strategic project communication skills to optimize project team relations and project outcomes. I offer 12 years of experience in Pharmaceuticals, in Rx Field Sales, Rx/OTC Market Research, AGILE/WATERFALL Clinical Research Operations and Clinical Supply Production. Most recently, I leveraged EMR/EDC databases and Digital Health vendors to help optimize Digital Health Clinical Recruiting. I focus on risk mitigation, team building, scheduling/budgeting to foster Practical Process Improvement (PPI) in projects. PROFESSIONAL EXPERIENCE:

PMP Student/Research Consultant: Milford, DE 11/24 — Present

• I continue to work on my PMI-PMP Certification course for a May 2025 Certification exam. I participate in short-term virtual equity research studies for GLG Research and other research groups. I also have local job interview cycles for Project Management roles, but the market remains soft under the New Administration in 2025.

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Contingent Project Manager, Bristol Myers Squibb/All Source PPS: Lawrenceville, NJ 11/23 — 7/24

• 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 AGILE projects. Trained on JIRA. I managed a $4.2 Million portfolio of Innovation/Digital Health projects, with vendors like Oracle Life Sciences and Deep 6 AI. My high- quality output supported BMS Leadership Team initiatives and clinical trial optimization, focused on Immunology & Hematology therapeutic areas. My monthly contract was renewed multiple times; however, my position was eliminated due to Corporate BMS corporate budget cuts and my request for FMLA time off. Sr. Program Manager, Cell/Gene Therapy, Catalent Pharma Solutions: Baltimore, MD 7/22 — 12/22

• Recruited 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. Using daily AGILE scrums, I tracked projects, motivated teams, and delivered BDS fill/finish batches to clients for clinical trial supply distribution. Delivered overdue Tech Transfer data packages to clients, despite massive CMC/QA department turnover.

• Executed two simultaneous Ophthalmic BDS fills for Phase II Clinical Trial Supply before resigning when I became aware of divisional financial viability (-28% YOY revenues). Catalent reorganized and was sold off in 2023. Project Manager III, Bio Services, Thermo Fisher Bio Services: Rockville, MD 5/21 — 6/22

• Recruited to Fisher Bio Services manage a $5+ MM portfolio of Commercial/DoD/Academic Cold-Chain Logistics projects. These AGILE biorepository projects included strategic US Dept of Defense vaccine storage & transport logistic projects, as strategic vaccines stockpiles moved through DoD distribution process worldwide.

• Stepping in for a TFS director on childbirth leave, I optimized vaccine allocation and disposal programs for Fort Detrick strategic research program under COVID restrictions with DoD Program Managers flawlessly.

• Also managed clinical trial supply for Astra Zeneca's Acalabrutinib (CLL) and NIDDK Diabetes Longitudinal Trial clinical supplies. Led/executed diagnostic GCP kitting assembly projects (Lab Ware LIMS) for commercial clients. Thomas C. Calloway, MBA (Page 2 of 2)

PROFESSIONAL EXPERIENCE (continued):

Digital Project/Content Creator, Quora.com: New York, NY 3/20 — 5/21

• During the COVID Pandemic, I wrote health/wellness content while at home, which drew attention from isolated site visitors to Quora.com and Quora.com management. My following grew in parallel to pandemic social isolation and general curiosity about free health advice during COVID.

• I created content in response to Community Questions 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 Scientific Employment Policy, prohibiting freelance work. Associate Clinical Project Manager, Carelon Research, Inc.: Wilmington, DE 9/18 — 8/19

• Recruited 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. I used Lab Ware LIMS training modules.

• Within an AGILE Project Management framework, I maintained eTMF; utilized EDC, CRF and CTMS; site investigator agreements, ICF development, Investigator selection. Principal/Project Manager, Exuberant Energy NY, LLC: New York, NY 2/14 — 8/18

• During 2016-18, 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 during 2014-16.

• I conceived and executed benchmark analysis of worldwide Factor Xa Clinical Research, to 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 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. Market Research Manager, Advertising Publicis Rx/OTC Division New York, NY

• Sr. Market Research Analyst Wyeth International Philadelphia, PA

• Sr. Rx Field Representative Janssen / J&J Manhattan, NY (#1 of 10) EDUCATION:

• Columbia University Graduate School of Business New York, NY Master of Business Administration

• Boston University College of Communications Boston, MA Bachelor of Science, Communications Technology Management CERTIFICATIONS:

• Project Management Institute Newtown Square, PA

-CAPM (Certified Associate in Project Management) (2019-2024) SOFTWARE:

• Microsoft Office 365 (Excel, Word, PowerPoint, Teams, Outlook, Visio, SharePoint, Project).

• LIMS (Lab Ware) Track Wise; Compliance Wire, Documentum; Smart Sheet; ICH-9/HIPAA/cGMP/GLP.

• RWE/RWD; Medline; EDC/EMR; CTMS; eTMF, JIRA, AGILE/PMP studies PMBOK 7.0 in progress.

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