Clinical Data Manager

Role Overview: You will be responsible for overseeing all data management activities related to Phase I-IV clinical trials, ensuring adherence to ICH/GCP guidelines. Your role is crucial in producing quality work products and meeting project timelines. Key Responsibilities: - Participate as the primary data management representative on multidisciplinary project teams and act as the main point of contact for data management interactions with the Sponsor. - Contribute to protocol development, review of clinical study reports, statistical analysis plans, and development of data dictionaries. - Review and provide inputs on CRF design, database design, data validation plans, and revisions to Standard Operating Procedures. - Manage resource planning methodologies, project management, study deliverables, timelines, and the Sponsor change order process. - Assist senior management in identifying and implementing processes to enhance efficiencies, evaluating potential data management solutions, and supporting individual development and training. Qualifications Required: - Bachelor's/Master's degree in computer science, statistics, clinical research, or biotechnology from an accredited institution. - Minimum of 5 years of data management experience. - Project management experience is necessary. - Previous work experience at a Clinical Research Organization (CRO) or CRO management experience in data management is essential. - Direct management of employees within Clinical Data Management is preferred.,