Michael B.

Associate Director, Feasibility, Functional Service Partnership Solutions, PPD Clinical Research Services, Part of Thermo Fisher Scientific

Springfield, Illinois, United States

About

A skilled communicator and energetic professional with over 13 years of combined strategic feasibility, research and writing experience in bench studies and clinical trials. Able to communicate effectively with all organizational levels, build relationships of trust, and enlist the participation of team members to drive a successful feasibility endpoint. Author of numerous peer-reviewed publications and presentations at national conferences. Expertise • Clinical Trial Feasibility Strategy, Clinical Trial Site and Patient Identification, Clinical Trial Optimization, Clinical Trial Innovation in Feasibility and Study Start-Up, Clinical Research Writing, Clinical Protocol Writing, Clinical Research Development, Clinical Trial Reporting, Medical Writing, Regulatory Writing, Scientific Writing, Population Health Science • Presentations and proposals for client bid defense, clinical trial optimization and feasibility study start-up services and strategy for awarded studies • Seminar and professional conference presentations • Data analysis • Neuronal cell culture, stimulation and electrophysiology • Proficient in numerous statistical, writing and graphics programs including: o Numerous PPD internal clinical trial databases o Numerous external/commercial clinical trial databases o MATLAB o ProStat o SPSS o SAS o Image-Pro o Adobe Photoshop, Illustrator o Microsoft Office (Word, Excel, PowerPoint) o Quark o ATS Skills • Strong collaborative communication skills in project development and optimization • Statistical Interpretation • Diverse writing skills in clinical research and basic science • Public Relations • Sports and Business Journalism

Experience

  • Thermo Fisher Scientific (Full-time · 3 yrs 2 mos)
    • Associate Director, Feasibility, Functional Service Partnership Solutions, PPD CRS
      Dec 2024 - Present · 1 yr 7 mos

      Current FSP Assignment (began May 2023) Dedicated Clinical Operations Planning and Feasibility Analyst at Major Pharma Company Research and Data Analysis/Presentation Protocol Optimization and Development Study Recruitment Modelling Recruitment Modelling Platform Testing and Development In House Studies Database Testing Feasibility Strategy

    • Clinical Operations Planning and Feasibility (PPD FSP)/PPD FSP Business Unit Strategist
      May 2023 - Feb 2025 · 1 yr 10 mos

      Dedicated Clinical Operations Planning and Feasibility Analyst at Major Pharma Company (via FSP) Research and Data Analysis/Presentation Protocol Optimization and Development Study Recruitment Modelling Recruitment Modelling Platform Testing and Development (team) In House Studies Database Testing (team) Feasibility Strategy

  • Feasibility Strategist at PPD, part of Thermo Fisher Scientific
    Dec 2021 - Feb 2025 · 3 yrs 3 mos

    Currently working on GSK FSP involving feasibility analytics/strategy, project modelling and protocol development (from May 2023 to present).

  • PPD (6 yrs)
    • Feasibility Strategist
      Jun 2018 - Dec 2021 · 3 yrs 7 mos

      Feasibility Strategist PPD Site and Patient Access Provides input to departmental strategy and the ongoing innovation of the range of feasibility services. Delivers accurate and robust data driven operational strategy recommendations beginning at the request for proposal stage through the end of the site ID process to drive a successful study endpoint. Leads cross functional teams to coordinate trial optimization efforts.

    • Medical Writer - Feasibility Services
      Jan 2016 - Dec 2021 · 6 yrs

      Strategic Feasibility Writer/Analyst for Gen Med/Neuro/CV Research, prepare and critically evaluate clinical trial feasibility data. Coordinate preparation of feasibility reports, proposals, and bid defense presentations. Research, write, and edit comprehensive high quality reports and proposals that incorporate strategic input from medical, regulatory, and project management staff along with applicable published literature/databases.

  • SIU School of Medicine (8 yrs 9 mos)
    • Medical Writer (Clinical Research Development/Researcher III)
      Jun 2013 - Jan 2016 · 2 yrs 8 mos

      This was a clinical research development position focused on medical writing. I was an active participant on several research development coordination teams. My document writing contributions included: clinical trial protocols, regulatory documents, IRB documents, new device invention protocols, quarterly and annual clinical trial reports, scientific/medical manuscripts, grants, budgets etc..

    • Neural Networks Scientist (Medical Microbiology, Immunology and Cell Biology/Researcher II)
      May 2007 - May 2013 · 6 yrs 1 mo

      Writing • Wrote and edited numerous manuscripts describing neural networks experimental outcomes research • Wrote experimental protocols • As part of the Neural Networks team wrote and edited NIH and NSF grants and progress reports Research • Reconstruction of hippocampal sub-regional circuits on multi-electrode arrays connected through axons confined in micro-tunnels • High resolution neuronal networks on MEAs with micro-contact printing using PDMS stamps Duties • Planned, prepared, and performed experiments using rat hippocampal neurons in cell culture (dissected all regions of the rat brain including dissection of the rat hippocampus into CA3, CA1 and DG regions) • Acquired electrophysiological and microscopic fluorescence signals from neurons using Multi-Channel Systems MEAs, amplifiers and software • Collected and plotted data for reporting in poster format to collaborators and at large meetings • Trained and supervised Researcher I staff and SIU-SOM students • Ran Matlab scripts for data analysis and edit programming

  • Previous employment involving writing at Various, see description
    Jan 1998 - Dec 2012 · 15 yrs

    Sports Staff Writer, The State Journal-Register. 2002-2012. Reported on local sporting events in Springfield, Illinois and surrounding counties. Created and edited the statistics page of the sports section (AGATE). Text/Graphic Artist, IBM. 2000-2001. Assisted with preparing IBM presentations for client meetings (charts, graphs, text content). Helped convert numerous Lotus presentations into Microsoft Powerpoint presentations. Technical Writer (lottery and phone card program), GTECH Corp. 1999. Wrote and edited technical documents describing the formation and execution of a phone card program promotion with the Illinois Lottery. Correspondent/Staff Writer, Springfield Business Journal. 1998. Reported on local businesses in Springfield, Illinois and surrounding counties.