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Job #02619

About our client Our client is a well-established CRO headquartered on the east coast with a reputation for excellence in conducting Phase 1 studies. The company has recently experienced significant growth and boasts of an empowering corporate culture that is focused on the professional development of its employees. Position Location Director of Data Management Pennsylvania Salary Reports to Highly competitive package, commensurate with experience Management 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) Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific dataManage, plan and coordinate the activities of the Data Management Group 12) Ensure that the data collected is error free and meets the requirements of the study sponsor and internal quality standards 13) Work closely with the management to prepare and execute data management plans to manage projects from the beginning to the end 14) Ensure that the Data Management Group is aligned with business objectives as well as in compliance with all FDA requirements 15) 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 16) Co-ordinate with database programmers/QA to create and validate database design and edit check specifications 17) Oversee hiring, daily management, training and development of Data management staff 18) Develop and update SOPs associated with the data collection, handling and the review processes to meet regulatory compliance and operational needs 19) Oversee coding of safety data using the industry standard coding directions 20) Assist with the validation of statistical output for the final report 21) Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data 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) Ability to manage staff, projects and resources to meet timelines and budgets 7) Ability to manage multiple and varied tasks and prioritize workload with attention to detail 8) Effective problem solving, collaboration and teamwork skills 9) Excellent organizational skills 10) Willingness to travel – up to 20%