Sr Clin Data Assoc

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

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