Catching Up with the Evolving World of Project Management for Trials

Deb Rosenfelder

Deborah Rosenfelder, BSN, RN, CCRC, FACRP, Becton Dickinson

In days gone by, it was pretty self-evident what the expectations were for a “project manager” of a clinical trial program—the person with that title managed a small team of functional leads, kept communication flowing between the stakeholders, “put out fires,” pulled data, and generally avoided deviations from the defined processes of the study.

My, how times have changed. According to ACRP 2018 workshop presenters Deborah Rosenfelder, BSN, RN, CCRC, FACRP, a clinical data scientist with Becton Dickinson, and Suheila Abdul-Karrim, BSc Hons, CCRA, FACRP, RQAP-GCP, a clinical research consultant, auditor, and trainer, project managers are now more like proactive action heroes than mostly passive caretakers. In their pre-conference workshop on “Clinical Research Project Management: Developing and Utilizing Essential Tools” today (April 27), Rosenfelder and Adbul-Karrim highlighted the four basic elements of a project that a successful project manager must simultaneously attend to:

  • Scope: Project size, goals, requirements, quality
  • Resources: People, equipment, material
  • Time: Task durations, dependencies, critical path
  • Money: Costs, contingencies, profit

Project managers are thus expected to “provide solutions and ownership, be in the driver’s seat, and serve as project leaders,” the presenters indicated. They must also handle such tasks as managing significant changes midstream in trials, reconciling different views and focusing stakeholders on the project’s vision, and inspiring full engagement in the project from a cross-functional team in order to align activities with the customer’s goals.

Diving into the complexities of such project manager tasks as developing study timelines and work breakdown structures, gauging feasibility, managing risks, and conducting bid defenses following delivery of a response to a request for proposal to the project sponsor, Rosenfelder and Abdul-Karrim demonstrated how much the scope of the project manager role has evolved in recent times. Even the “soft skills” of team building, time management, organization, and setting goals and priorities have risen to the level of seriously impacting how successful the modern project manager may be at juggling so many disparate functions, they said.

Author: Gary Cramer