Clin Data Assoc Ii
7 months ago
**Summarized Purpose**:
- Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical devices**Essential Functions and Other Job Information**:
- Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required.
- Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package.
- Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports.
- Produces project-specific status reports for CDM management and for clients on a regular basis.
- Performs data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations as well as Data Listing reviews.**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 and ability to use interactive computer programs
- Good written and verbal communication skills and a strong command of English language and grammar
- Good organizational and analytical/problem-solving skills
- Ability to work productively with moderate supervision
- Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
- Strong customer focus and excellent interpersonal skills.
- Proven flexibility, adaptability and ability to work in a team environment or independently as needed
- Must demonstrate good judgment in making decisions
- Knowledge of medical/clinical trial terminology
- Understands project protocol and Data Validation Manual
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Clin Data Assoc Ii
7 months ago
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