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.

• 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

• 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