Clinical Research Project Management: Operational Leadership for Clinical Trials (Clinical Research & Regulatory Affairs)

Updated in 2026 to reflect current clinical trial operating practices. Clinical trials succeed or fail in execution. Timelines slip due to numerous operational issues unrelated to enrollment. Budgets erode when change is unmanaged. Quality findings usually trace back to preventable process breakdowns.Clinical Research Project Management: Operational Leadership for Clinical Trials is a field-tested guide to delivering clinical trials with disciplined planning, transparent governance, and inspection-ready documentation. It is written for project managers, clinical operations leaders, and cross-functional stakeholders who need an operating model that holds up across sponsors, CROs, vendors, and investigative sites.Rather than treating project management as generic theory, David Lew maps core PMI concepts directly to trial delivery, including start-up readiness, vendor ecosystems, integrated planning, budgeting and forecasting, operational controls, risk-based quality management (RBQM), and closeout. The result is a pragmatic playbook for running trials without losing control of scope, decision rights, or evidence.Inside you will learn how to:Translate protocol intent into executable scope, schedules, and baselinesEstablish governance, change control, and escalation pathways that work in outsourced modelsManage vendors, data flows, systems enablement, and trial documentation as controlled deliverablesBuild dashboards, key performance indicators (KPIs), key risk indicators (KRIs), logs, and decision discipline that drive actionImplement risk, quality, and compliance practices that protect participants and data integrityExecute closeout, database lock (DBL), clinical study report (CSR) delivery, and lessons learned with traceable evidenceRead it end to end to build your operating model, then use it as a desk reference during planning, execution, and inspection preparation. Read more