Responsible for the development of clinical database systems for assigned projects. Collaborates with various departments to design, document, test and implement clinical data studies. Develop systems for organizing data to analyze, identify and report trends.
1. Develop and maintain clinical database programming standards.
2. Lead in designing, developing, validating, and maintaining clinical study databases for clinical trials using validated applications.
3. Provide complete and accurate documentation of study databases consistent with SOPs, protocols, programming standards, and data management plans.
4. Design, build and validate clinical study databases (paper and/or EDC).
5. Define, implement and test data quality checks according to the data validation specifications.
6. Design and/or manage a global library of standard objects.
7. Create and/or maintain PL/SQL standard routines/packages as applicable
8. Manage and update medical coding dictionaries, including but not limited to MedDRA and WHODrug.
9. Batch load external data from vendors (e.g., central lab data).
10. Manage user accounts
11. Lead efforts in writing departmental documentation (e.g., training documents, processes, etc.).
12. Participate in other clinical programming and data management activities, as required.
13. Manage data entry processes for studies; develop data entry guidelines, train data entry staff on study specific processes and set-up, and make necessary modifications based upon feedback.
14. Provide analysis and feedback (questions, issues and possible resolutions) to the Director of Clinical Data Management and/or project team on Clinical Data Management tasks, systems or processes.
15. Communicate as necessary regarding project status/issues.
This position is part-time temp with opportunity to turn into full time permanent.
Bachelor's degree in related scientific discipline and two to five years related industry experience or equivalent. Excellent written and verbal communication skills. Strong organizational, communication and prioritization skills. Ability to handle multiple projects and work in a team environment. Proficiency with Microsoft Word, Access, Excel, PowerPoint. Experience with coding dictionaries (WHODRUG, MedDRA). Experience with database design and development, PLSQL and VBA required. Experience in SAS helpful but not required.
Temporary - Part Time
To be determined
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