Clinical Operations

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement
• Lead project team to ensure quality, timelines and budget management
• Accountable for the financial performance of each project
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements
• Accountable for all project deliverables for each project assigned
• Responsible for quality and completeness of TMF for assigned projects
• Accountable for maintenance of study information on a variety of databases and systems
• Responsible for study management components of inspection readiness for all aspects of the study conduct
• Oversight for development and implementation of project plans
• Plan, coordinate and present at internal and external meetings
• Prepare project management reports for clients and management
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals
• Develops strong relationships with current clients to generate new and/or add-on business for the future
• May participate in bid defense meetings where presented as potential project manager
• May be required to line manage other project management team members and clinical monitoring staff

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Clinical Project Manager – Regional or Global Experience