The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met. Participate as the primary data management representative on the QED multidisciplinary project teams and as the primary point of contact for all data management interactions with the Sponsor. Participate in protocol developments and review, in review of clinical study reports and statistical analysis plan, in the development of data dictionaries complete with variables, value specifications and coding standards, and in monitoring the quality of data management processes, data, and performance. Review and provide inputs to CRF design and CRF Completion Instructions, database design, data management/data validation plans, data entry guidelines, and revisions to the Standard Operating Procedures. Manage resource planning methodologies and project management to ensure study deliverables and timelines are met in collaboration with the Sponsor, the Sponsor change order process, and to ensure effective communication exchange between the multidisciplinary project teams. Assist/Work with Sr. Management in identifying, developing, and implementing processes to improve/enhance time and cost efficiencies, to provide current information and potential impact of changes on project deliverables and timelines, to identify trouble-shoot issues and provide proposed solutions for problem resolution, to evaluate future potential data management solutions (e.g. functional service provider models, EDC systems) and prepare a business plan, to individual development, training, knowledge, and expertise through research, technical bulletins, and attending appropriate seminars, and to endorse and convey QED's corporate mission statement. Qualifications/Experience: - Bachelor's/Master's degree in computer science, statistics, clinical research, biotechnology, from an appropriately accredited institution. - Minimum of 5 years of data management experience. - Project management experience is required. - Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required. - Direct management of employees within Clinical Data Management is preferred.,
