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Job #03252

About our client Our client is a leading pharmaceutical company. With a focus on the development and commercialization of various therapeutics in disease prevention, they aim to improve the quality of life for patients worldwide. They are headquartered in Texas with Operations in Europe and India. Position Location Director of Data Management Texas Salary Highly competitive package, commensurate with experience Responsibilities 1) Work closely with the management to prepare and execute data management plans to manage projects from the beginning to the end 2) Ensure that the data collected is error free as well as meets the requirements of the study sponsor and internal quality standards 3) Manage, plan and coordinate the activities of the Data Management Group 4) Ensure that the Data Management Group is aligned with business objectives as well as is compliant 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) Coordinate with database programmers/QA to create and validate database designs as well as edit check specifications 7) Oversee hiring, daily management, training and development of Data Management staff 8) Develop/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) Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data 12) Monitor India operations and report on progress to management Requirements 1) Bachelor’s degree in a relevant scientific discipline 2) 10+ 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 5 years of experience in managing a Data Management Group 4) Working experience in a service environment (preferred) 5) Practical experience in SQL and SAS 6) Ability to influence, build relationships with regulatory bodies, associations and stakeholders as well as successfully negotiate 7) Ability to manage staff, projects and resources to meet timelines as well as budgets 8) Ability to manage multiple as well as 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%)