Clinical Data Manager

Role Overview: As the Clinical Data Manager, you will be responsible for overseeing all data management activities related to Phase I-IV clinical trials. Your role will involve ensuring compliance with ICH/Good Clinical Practices (GCP) and other relevant guidelines to maintain high-quality work products and meet timelines and deliverables. Key Responsibilities: - Participate as the primary data management representative on the QED multidisciplinary project teams. - Serve as the main point of contact for all data management interactions with the Sponsor. - Contribute to protocol developments and reviews, as well as review of clinical study reports and statistical analysis plans. - Assist in the development of data dictionaries including variables, value specifications, and coding standards. - Monitor the quality of data management processes, data, and performance. - Review and provide inputs on CRF design, CRF Completion Instructions, database design, data management/data validation plans, and data entry guidelines. - Recommend 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. - Oversee the Sponsor change order process and facilitate effective communication exchange between the multidisciplinary project teams. - Assist and work with Sr. Management to identify, develop, and implement processes for improving time and cost efficiencies. - Provide insights on the potential impact of changes on project deliverables and timelines. - Troubleshoot issues and propose solutions for problem resolution. - Evaluate future potential data management solutions (e.g., functional service provider models, EDC systems) and prepare a business plan. - Enhance individual development, training, knowledge, and expertise through research, technical bulletins, and attending seminars. - Endorse and convey QED's corporate mission statement. Qualifications Required: - Bachelor's/Master's degree in computer science, statistics, clinical research, or biotechnology from an appropriately accredited institution. - Minimum of 5 years of data management experience. - Project management experience is required. - Previous work history at a Clinical Research Organization (CRO) or CRO management experience in data management is necessary. - Direct management of employees within Clinical Data Management is preferred.,