CRO GOVERNANCE, OPERATIONS, BIOSTATISTICS/DATA eisen

PERSONAL PROFILE

  • Expert clinical data sciences professional leveraging 20+ years of experience in research computing and
    10 years proven leadership in operational aspects of drug development at CROs.

EXPERTISE

Drug Development Operations; Vendor Selection and Quality Oversight; Development and Evaluation of Project Scope and Specifications; Analytical Review and Coordination of Project Management Plan and Timeline, Clinical Monitoring Plan, Risk Mitigation Plan, Data Management Plan, eCRF / CRF Completion Guidelines, User Acceptance Testing, and Statistical Analysis Plan; Data/Statistics Strategic Resourcing; SOPs; Medical Writing; Business Development; and Leadership.

Therapeutic Areas of Expertise: neuroscience (Tourette syndrome, Parkinson’s disease, Fragile X syndrome, autism, ADHD, pain), respiratory (cystic fibrosis), dermatology (acne vulgaris), oncology (solid tumor), ophthalmology (glaucoma, age-related macular degeneration, pediatric visual impairment), and virology (HCV).

Has ten publications.

PROFESSIONAL EXPERIENCE
Managing Partner, Edgerton Data Consulting, LLC

Director, Strategic Partnerships−Biometrics, Chiltern International (formerly Theorem Clinical Research)

Assistant Vice President, Operations, Assistant Director, Assistant Sector Lead, Rho, Inc., Chapel Hill, NC

Applications Specialist, University of North Carolina-Chapel Hill

Resource Management and Leadership
Found best-fit CRO/vendors for sponsors and provided vendor oversight. Developed and evaluated project scope and specifications; critically reviewed vendor proposals, budgets, plans, tools, and resources; and provided analytical review and coordination of consolidated comments of CRO deliverables (project management plan/timelines, clinical monitoring plan, risk mitigation plan, data management plan, eCRF/CRF completion guidelines, user acceptance testing, and statistical analysis plan). Provided strategic resourcing across data management, biostatistics, statistical programming, and data standards. Managed staff/contractors for clinical trial projects, including project management, clinical operations, data management, biostatistics, and medical writing.

Strategic Partnerships
Primary operational management contact for strategic clients and key relationship manager/primary contact for customer escalation plan. Launched and grew statistical programming Functional Service Provider (FSP) for mid-sized biopharmaceutical company in nine months from staff of five to 75. Developed and implemented CRO/Sponsor governance plan with key performance indicators, and instituted new strategic initiatives to better serve client needs and grow business. Led and managed project teams to ensure profitability of projects and customer satisfaction. Participated in proposal and budget development with project leads and communicated analysis of impact on company operations to CEO and VP Finance. Responsible for profit and loss of FSP by reviewing Statements of Work, negotiating rates and unit prices, coaching managers and project leads on deliverables timelines, and setting and managing expectations with sponsors. Worked with business development and project management to review bids, proposals, and scope changes, and participated in bid defenses and capabilities presentations.

SOPs
Developed SOPs for statistics and statistical programming for in vitro diagnostics company, including SOP and template for project-specific statistical validation plan using risk-based principles.

Statistical Programming and Data Management
Verified CRO biometrics deliverables via SAS programming and User Acceptance Testing for clinical database. Reviewed specifications and provided comments for SDTM, ADaM, and CDISC-related deliverables (SDTM/ADaM datasets, Define.xml, Reviewer’s Guides, aCRF, Pinnacle 21 reports). Reviewed and commented on data science- related study plans (data management plan, statistical analysis plan, statistical quality control plan, etc.). Supervised statistical programming personnel, ensuring completion of programming tasks for multiple concurrent studies.

 

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