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.
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 & Abilities: \xef\x82\xb7 Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations \xef\x82\xb7 Strong attention to detail and skill with numbers \xef\x82\xb7 Good written and verbal communication skills \xef\x82\xb7 Good analytical/problem-solving skills \xef\x82\xb7 Ability to maintain a high degree of confidentiality with clinical data and client\'s proprietary data \xef\x82\xb7 Strong customer focus and excellent interpersonal skills. \xef\x82\xb7 Proven flexibility and adaptability \xef\x82\xb7 Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands \xef\x82\xb7 Knowledge of medical/clinical terminology \xef\x82\xb7 Understands project protocol and DVM \xef\x82\xb7 Proven ability in achieving applicable technical competencies per the DM competency gri
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