Associate Clinical Data Manager Job Vacancy in Labcorp Bengaluru, Karnataka – Updated today
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Company Name : Labcorp
Location : Bengaluru, Karnataka
Position :
Job Description : Job Overview:
Review clinical trials data in accordance with [Global] Data Management Plans and applicable standardized data management processes (Standard Operating Procedures, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data and run ancillary programs (e.g. special listings, reconciliation discrepancy listings) used to support the review of clinical trial dataKey responsibilities
Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database
Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application
Perform reconciliation of the clinical and safety databases, reconciliation of central laboratory and/or third party vendor data (electronic Case Report Forms, electronic Diary, specialty laboratory, etc.) and aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation
Apply quality control procedures and checks to ensure data quality standards (client and LabCorp) are achieved
Serve as a reviewer of project documents such as protocols, electronic Case Report Forms and electronic Diary, monitoring conventions, electronic Case Report Forms completion guidelines, etc.
Assist with the development of Global Data Management Plans and Quality Management Plans that will deliver accurate, timely, consistent, and quality clinical data
Assist in the development of the clinical data model and/or database design and annotate the electronic Case Report Forms) according to these specifications, the creation of data acquisition conventions and data review guidelines / edit check specifications consistent with the clinical data model, [statistical] analysis plans, and electronic Case Report Forms completion /monitoring
conventions and the development and testing of data management system edit / data validation checks and special listings / procedures used as tools for the data review and discrepancy management activities. Interact and collaborate with other project and specialty team members (clinical, programming, statistics, Clinical Data management technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality
Support the training of project staff on project-specific, global, standardized data management processes, maintain technical data management competencies via participation in internal and external training seminars and review literature and research technologies/procedures for improving global data management practices
Education/Qualifications:
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).
Experience:
6-8 yrs of relevant DM experiance
This post is listed Under Healthcare
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