Lead all aspects of the data management function by contributing to data management strategic decisions and executing day to day activities required to create and maintain quality clinical databases.
1. Contribute towards process improvement, data standards and efficiency gaining initiatives.
2. Participate in technology improvement/implementation efforts.
3. Develop and execute data management plans and other data management documentation across all studies to ensure consistency.
4. Coordinate, facilitate, and participate in all data management activities during the study lifecycle.
5. Provide leadership to assigned staff by leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
6. Run data checks and identify data queries.
7. Specify and create new queries and reports to assist the data review process.
8. Monitor and report on the database status in terms of enrolment, open and resolved queries, and other metrics.
9. Coordinate database validation activities as requested.
10. Execute data export activities and building SDTM compliant databases in SAS.
11. Import data from external databases into REDCap databases.
12. Interact with database entry, management, and clinical staff as needed to assist in resolving questions and issues.
13. Perform other duties as assigned.
Education and Experience
Bachelor’s degree in data management, database programming, clinical trials or a related field. 5 years of data management experience. Experience with one or more database products and SQL. Experience programming in SAS, REDCap database, SDTM and CDISC database standards, PHP Scripting, and HTML are preferred but not required.
Knowledge, Skills, and Abilities
Advanced knowledge of Data Management processes and systems including new technologies, and proven leadership skills within a data management function, Good knowledge of SDTM requirements. Excellent organizational skills and demonstrated ability to delegate and monitor quality of outputs. Ability to establish and maintain effective internal and external working relationships. Ability to effectively apply knowledge and skills in a highly-organized fashion while adhering to regulatory guidelines, Standard Operating Procedures and customer expectations. Ability to act as an expert for Data Management processes.
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