Bangalore, Karnataka, India
15 hours ago
Clinical Data Associate II

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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. 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. Works on difficult or complex assignments requiring considerable judgment and initiative to resolve issues. Understands implications of work and makes recommendations for solutions and / or new procedures. As a skilled or highly skilled specialist, completes tasks in resourceful and / or creative ways, and may contribute to the development of concepts and techniques. May act independently on determining methods and procedures on new assignments. May be a facilitator and / or team leader (formal or informal). Contacts are frequent with individuals representing outside organizations, and / or individuals of significant importance within the company. Contacts involve planning and preparation of communications, requiring skill, tact, persuasion and / or negotiation to accomplish the objectives of the communication. 

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