Covance Clinical Data Associate in Bangalore, India
Work Location : Bangalore
Serve as a member of the project team with primary responsibility for performing clinical data review, query generation / resolution and reconciliation activities to support the delivery of clinical data according to client quality and integrity specifications, project timelines and productivity targets
Essential Job Duties:
Perform all data management tasks as appropriate to include, but not to be limited to: data review and query management to ensure that quality standards (both internal and client) are achieved.
Perform reconciliation of the clinical database against safety data, laboratory data and other third party data as appropriate.
Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data.
Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database as required.
Run ancillary programs (diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data
Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required.
Create or review data listings for dose escalation and safety assessments as needed.
Assist with creation/reviewing Edit Check Specifications
Create User Acceptance Test Scripts from Edit Check Specifications and create dummy data to test edit checks and to test database screen functionality
Assist in creation of Study Test Plan and Study Test Report documentation
Perform Database Decommissioning and create supportive documentation
Assist in preparing Access Rights forms for EDC database
Support team members by creating forms/memos as required
Filing of Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
Running study status reports
Performs any other duties as assigned
¨ University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
¨ Fluent in English, both written and verbal
¨ Know ledg e of Covance and the overall structure of the organization
¨ Knowledge of Covance standard operating procedures
Minimum of 2 year of clinical research experience.
Demonstrated interpersonal skills
Good oral and written communication skills
Demonstrate ability to work in a team environment and collaborate with peers
Demonstrate good organizational ability, communication and interpersonal skills
Demonstrate team working stills and good collaborator skills
Additional experience may be substituted for education requirements
Job Number 2018-17128
Job Category Clinical Operations
Position Type Full-Time
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