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Clinical Project Manager job in King of Prussia at RX2 Solutions, LLC

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Clinical Project Manager at RX2 Solutions, LLC

Clinical Project Manager

RX2 Solutions, LLC King of Prussia, PA Full Time
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TITLE: Clinical Project Manager
TYPE: Direct Hire
LOCATION: King of Prussia, PA
START DATE: August 2021
 
Our client, located near King of Prussia, PA, is looking to hire a Clinical Project Manager for a full-time opportunity. This person will be primarily responsible for ensuring all clinical programs follow SOP, Regulatory regulations, local/federal laws, and all the standards governing the clinical studies. This person will also manage the risk, supplier control, and SOP per study.
 
Main Responsibilities:
  • Develop and maintain the clinical risk management program. This includes creating Key Risk Indicators for clinical and validation studies, vendor selection, and site/system integrations.
  • Coordination of team selection and meetings to ensure project schedules are kept.
  • Responsible for the vendor management program and clinical site maintenance by conducting audits and risk assessments.
  • Manage CAPAS and departmental data using Quality Management System (QMS).
  •  
  • Working with CRA and SADS for database design, rules, and validation.
  • Providing support to the team with data entry, query generation, EDT, and CRF tracking.
  • Follow GCP protocols for data management.
 
Qualifications:
  • 4-year college degree required with 2 years of experience working ins clinical research, clinical laboratory, or FDA regulated environment.
  • Extensive knowledge of GCP, FDA regulations, and Data Management.
  • Excellent communication skills, both written and verbal.
  • Ability to work in a fast-paced, deadline-oriented environment.
 

Recommended Skills

  • Risk Analysis
  • Clinical Research
  • Clinical Research Associate
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  • Scheduling
  • Auditing
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Job ID: 21-00169

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