One of our growing CRO clients is currently looking for an additional Clinical Project Manager who will be a critical team member reporting directly to the Director of Clinical Affairs, to support clinical trial operations for the firm's clientele. Primary responsibilities will include providing oversight and management for all clinical aspects of the development and execution of clinical trials/protocols. The CPM will execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.
* Ensure that clinical studies are properly resourced, managed and executed in accordance with established timelines and quality standards.
* Ensure that studies are conducted according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals and procedures.
* Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (PIs, Study coordinators, etc.)
* Lead and direct project team to ensure deliverables meet project timelines.
* Track and report on progress of study including site activation, patient enrollment, and monitoring visits.
* Develop Clinical Monitoring Plan and other project documents as assigned.
* Manage clinical monitoring functions of clinical studies.
* Approve reports and study communications generated by the project team for distribution to sponsors and investigators.
* Ensure Trial Master File is accurate and complete throughout the lifecycle of the project.
* Assist with professional development for Clinical Research Associates and Clinical Associates.
* Maintain knowledge of current GCP, FDA, and other applicable regulations.
* Other duties as assigned by Senior Director, Clinical Affairs
* Assist with site audits activities as needed.
* Maintain current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current clinical related developments in the assigned therapeutic areas.
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