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Job #03067

About our client Our client is a reputable, mid-size CRO that is experiencing unprecedented growth. The company has an experienced management team and innovative marketed products. This is a great opportunity for the right candidate. Position Location Director of Clinical Data Management Chicago, Illinois Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage, plan and coordinate the activities of the Data Management Group 2) Ensure that the data collected is error free and meets the requirements of the study sponsor and internal quality standards 3) Work closely with the management to prepare and execute data management plans to manage projects from the beginning to the end 4) Ensure that the Data Management Group is aligned with business objectives as well as in compliance with all FDA requirements 5) Work closely with Clinical Trials Division, statisticians and other staff as appropriate, to develop CRFs to ensure that the information required for statistical analysis is present 6) Co-ordinate with database programmers/QA to create and validate database design and edit check specifications 7) Oversee hiring, daily management, training and development of Data management staff 8) Develop and update SOPs associated with the data collection, handling and the review processes to meet regulatory compliance and operational needs 9) Oversee coding of safety data using the industry standard coding directions 10) Assist with the validation of statistical output for the final report 11) Ensure the success of the company's India operations and coordinate the activities of the Data Management Group 12) Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data 13) Ensure that the data collected is error free and meets the requirements of the study sponsor Requirements 1) Bachelor’s degree in a relevant scientific discipline 2) 7 years of experience in a clinical research data handling environment with relevant practical experience in protocol reviewing/CRF designing, clinical study databases and data management 3) Minimum 3 years of experience in managing a data management group 4) Experience in service environment preferred 5) Practical experience in SQL and SAS 6) Previous experience of managing overseas staff in India 7) Ability to manage staff, projects and resources to meet timelines and budgets 8) Ability to manage multiple and varied tasks and prioritize workload with attention to detail 9) Effective problem solving, collaboration and teamwork skills 10) Excellent organizational skills 11) Willingness to travel – up to 20%