IQVIA seeks a Local Clinical Project Manager in Frankfurt to lead country-level study teams delivering clinical trial components on schedule and budget. The role encompasses site selection, regulatory submissions, monitoring coordination, and team leadership while ensuring compliance with ICH-GCP guidelines and German regulations.
Responsibilities
Lead Local Study Team (CRAs, CSAs) and ensure delivery of study commitments within country timelines and quality standards
Oversee site identification, qualification, setup, activation, monitoring and closure throughout study lifecycle
Coordinate regulatory submissions to EC/IRB and Regulatory Authority; prepare financial and clinical documentation
Plan and manage monitoring activities, review reports and advise monitors on study issues
Identify risks proactively, facilitate resolution of complex problems and organize regular team meetings
Requirements
Bachelor's degree in life science or equivalent qualification
3–5 years hands-on clinical operations experience (Project Lead or Clinical Operations Lead)
Strong knowledge of German clinical trial environment and local requirements
Prior project management experience at local level in clinical settings
Background in Oncology therapeutic area
Fluent German (native/C2 level) and very good English
Project leadership, budget management, risk management and solution-oriented mindset
... timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading the Local Study Teams, the Local Clinical Project Manager (m/w/d) may perform site monitoring as needed to support the flexible capacity model. The Local CPM is responsible ...
Your mission CatalYm GmbH is seeking a (Sen.) Project Manager to support the Head of Program Management and cross-functional program teams in translating development strategy into coordinated, executable plans. The role provides day-to-day project management support across clinical development activities, including integrated ...
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