Job Description
Summarized Purpose:
Performs all aspects of the data cleaning process, with minimal supervision, in accordance with GCP and SOPs/WPDs in order to assess the safety and efficacy of investigational products and/or medical devices.
Essential Function:
- Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required.
- Reviews data listings for accuracy and consistency of data.
- Acts as point person and subject matter expert for specialized study-specific processes.
- Generates, tracks and resolves data clarifications and queries and makes changes to the clinical database as required.
- Contributes to the improvement of data management processes on a global level.
- Produces project-specific status reports for management and/or clients on a regular basis.
- Provides training and work direction to junior staff as required
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Knowledge, Skills and Abilities:
- Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
- Strong attention to detail and skill with numbers
- Good written and verbal communication skills
- Good analytical/problem-solving skills
- Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
- Strong customer focus and excellent interpersonal skills.
- Knowledge of medical/clinical terminology
- Understands project protocol and DVM
- Proven ability in achieving applicable technical competencies per the DM competency grid