Under the direction of the Associate Director of Clinical Operations, the Senior Clinical Project Manager has responsibility for the comprehensive management of clinical studies from concept to completion.
Essential Job Functions:
· Manage clinical research activities including development of clinical study conduct strategy, execution of clinical trials, data coordination/management and reporting/communication of results
· On assigned studies, provide leadership for the clinical operations project team, working in close collaboration with the CRA and other functional group leaders for the execution of all services according to the project-specific scope of work
· Ensure clinical studies are conducted according to all applicable regulations, company procedures, and high ethical/quality standards allowing for clinical trial documentation to be in audit-ready condition
· Prepare and/or facilitate the review of case report forms, protocols, investigator’s brochures/instructions for use, informed consent forms, study operations manuals and regulatory reports
· Assist in the development of electronic data management and device management systems
· Assist in the submission and review of all clinical deliverables required for regulatory submissions
· Collaborate with clinical operations administration to identify and oversee trial-related training and any performance concerns of team members according to their individual needs
· Graduation from a 4 year accredited bachelor’s degree program
· A minimum of 5 years of clinical project management experience
· Knowledge of medical terminology, Federal regulations and ICH-GCP, time management and problem solving skills, and the research process
· Excellent verbal and communication skills and be able to work independently
This is a full time, Monday through Friday, in-office position.
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