Lead Data Management (DM) activities required to create and maintain quality clinical databases.
1. Create, test, run and update data edit checks to identify, submit, and resolve data queries.
2. Specify and create new data queries and listings/reports to assist/support the data review and cleaning process.
3. Monitor and report on the database status in terms of data abstraction/entry, open and resolve queries, perform data listing and quality reviews, as well as, producing or outlining programming needs to produce other study-related metrics as requested/needed.
4. Develop and/or assist in database design and database validation activities.
5. Assist/support DM Programming Operations in data export activities and building of SDTM-compliant SAS datasets.
6. Assist in data import from external data sources/databases into REDCap databases.
7. Interact with EMR abstraction, database entry, management, and clinical staff as needed to assist in resolving data related questions and issues.
8. Participates in team meetings/discussions as requested, collaboration with team members to meet or exceed program timelines and deliverables.
9. Perform medical coding assignment to identified clinical verbatim text (e.g. adverse events, prior/concomitant medications, medical history, surgical procedures, etc.) using appropriate coding dictionaries (MedDRA and WHODrug).
10. Support SOP reviews and updates, creation/design of standard forms, standard edit checks, and database builds, assist with the design of training guides related to the DM activities,
Education and Experience
Bachelor’s degree in data management, database programming, clinical trials or a related field. Minimum of 3 years of experience in data management. Experience with two or more DMS/database products. Programming knowledge in SAS or SQL (desired), REDCap database experience (desired) and/or multiple EDC/Web-based system experience, experience with SDTM and CDISC database standards, data abstraction and EMR process and support experience highly desired. Quality control process improvement experience, SOP development experience, and DM specific study documentation/training development experience. MedDRA and WHODrug training to support medical coding activities.
Knowledge, Skills, and Abilities
In-depth knowledge of data collection, reporting, and cleaning methodologies, as relates to clinical research and the collection of RWD and/or registry studies. Development of standards, development and review of data guidelines, as well as, DM and database training documentation applying knowledge of REDCap and/or EDC/Web-based system experience. SOP development and review, and development of DM specific study documents (DMP, DVP, data abstraction guidelines, etc.), related to DM services and support. Knowledge of medical coding activities (use of MedDRA and WHODrug coding dictionaries).
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