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Ensures project safety reviews and procedures are followed by conducting weekly safety checks and engaging in safety meetings and monthly review meetings. Supports the safety programs of the project a...
Work, and participate in reviews with various governing agencies for code compliance. They must demonstrate leadership experience in taking a project from planning, through design, construction to ope...
Oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and management, oversight of clinical team staff during study start-up, interim monitoring and clo...
Manage global clinical study teams, CRO’s and Vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines...
Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents...
Creates and manages overall operation of the entire clinical study including project planning, budget, and resource management. Serves as primary contact for sponsor and/or functional area representat...
Responsible for coordinating with Government Project Managers on projects requiring coordination with the Government and/or other contractors. Manage and coordinate activities for all internal resourc...
Manage the standard operating procedures of the department and ensure compliance with ICH GCP guidelines. Oversee the maintenance, review and implementation of Quality Control procedures...
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Provides internal data monitoring and Quality Assurance checks for compliance with GCP (Good Clinical Practices) SOPs (standard operating procedures) and Sponsor data requirements ...