CLINICAL PROJECT MANAGEMENT, TRIAL LOGISTICS,
OPERATIONS
Kohut

PERSONAL PROFILE

  • 30+ years in clinical drug development, with strong history in trial logistical and operational knowledge
  • 15+ years as a functional manager
  • 19+ years in project management
  • 20+ years in sound operational strategies, functional areas, and project resources

EXPERTISE

Clinical Project Management, Operational Strategies, Project Resourcing, Trial Logistics/Measures/Metrics, Prototype Data Reports, Remote Monitoring Processes, Payment Solutions, Clinical Operations SOPs, Project Management Tools (performance and trial oversight), Team F2F and Interactive Training/Guidance/Reviews, Department Infrastructure Development, Project Review, Budget Management, and Timeline Templates.

Therapeutic Areas: Oncology (chemotherapy-induced anemia, liquid/solid tumors – Phases 1-4); Radio Imaging (Phase 2); CNS (epilepsy – Phase 3); Cardiovascular (pulmonary hypertension and chronic heart failure – Phases 2 and 3); Endocrinology (acromegaly, mucopolysaccharoidosis – Phases 2 and 3); Hematology (blood replacement – Phase 3); Orthopaedic (painful shoulder – Phase 2); Nephrology (dialysis – Phase 3); and Rescue (multiple projects involving oncology trials, both internal and external rescues – Phase 2).

BS, Biology, Emporia State University, Emporia, KS; and Master of Divinity, Midwestern Baptist Theological Seminary.

PROFESSIONAL EXPERIENCE

Senior Director, Project Operations/Senior Director, Project Management, Clinipace Research

Developed trial measures and metrics from disparate data sources. Created prototype data reports via MS Excel pivot tables and MS Access database solutions, as well as a remote monitoring process document that is easily adapted to multiple therapeutic indications. Devised a grant payment solution that interfaced with proprietary EDC platform. Revised clinical operations SOPs (clinical monitoring, project management, document filing), and developed project management tools to improve performance and visibility of trial oversight.

Director, Project Management/Standards, United BioSource Corporation

Developed and presented foundational project management training modules covering communications, progress reporting, time and matrix management, performance expectations, MS Project basics, and project finances. Created and implemented basic department infrastructure components. Developed and moderated monthly project review engagement. Managed performance and provided operational guidance for projects managed by project managers.

Director, Project Management/Project Director/Senior Project Manager, PRA International

Authored two interactive computer-based training modules that received CEU credits by the Project Management Institute (PMI) for PMP-certified PMs. Generated MS Project timeline templates for full-service projects and country-specific submissions. Created career progression matrix for two levels of project managers, as well as career progression pathways for FMs and directors. Managed project portfolio of ~$50M.

 

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