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Job #03344

About our client Our client is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products for the treatment of patients with life-threatening diseases and incapacitating conditions. Position Location Director of Data Management Texas Salary Highly competitive package, commensurate with experience Responsibilities 1) Work closely with 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 and meets the requirements of the study sponsor as well as 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 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) Coordinate with database programmers/QA to create and validate database design as well as edit check specifications 7) Oversee hiring, daily management, training and development of Data Management staff 8) Develop and update SOPs associated with data collection, handling and the review processes to meet regulatory compliance as well as 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 the progress to management Requirements 1) Bachelor’s degree in a relevant scientific discipline 2) 8+ 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) Experience in service environment preferred 5) Practical experience in SQL and SAS 6) Effective problem-solving, collaboration, teamwork, negotiation and communication (written and oral) skills 7) Ability to influence and build relationships with regulatory bodies, associations as well as stakeholders 8) Ability to manage staff, projects and resources to meet timelines and budgets 9) Ability to manage multiple and varied tasks as well as prioritize workload with attention to detail 10) Willingness to travel (up to 20%)