Solutions Made Real
Serve as a member of the project team with Primary responsibility for clinical data review, query generation / resolution and reconciliation to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets
Job Title: Clinical Data Coordinator
Job Number : 2018-17766
- Review clinical trial data in according with Globasl data Management plan and applicable standardized data management processes to identify erroneous, missing, incomplete, or implausible data.
- Run ancillary programs (e.g. Diagnostics, special listings, reconciliation discrepancy listings) used to ussport the review of clinical trial data.
- Generate, resolve and track queries to address problematic data idetified during data review activities and apply proper modification / correction to the database.
- Apply quality control procedure and checks to ensure data quality standards(client and covance) are achieved.
- Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application.
- Assist with the reconciliation of central laboratory and / or third party vendor data (eCRF, edDiary, specialty laboratory, etc.)
- Assist with the 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.
- Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special lisitings / procedures used as tools for the data review and discrepancy management activities.
- Support the training of project staff on project-specific, global standardized data management processes.
- Perform other duties as assigned by management.
- 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)
- In lieu of the above requirement, approximately 18 months experience in related field (e.g. pharmaceutical, laboratory, data analysis) incorporating approximately one year’s clinical data management experience will be considered.
- Knowledge of drug development process.
- Knowledge of effective clinical data management practices
- Knowledge of ICH guidelines and GCP including regulatory requirements for the conduct of clinical development programs.
- Knowledge of Covance and the overall structure of the organization.
- Knowledge of Covance standard operating procedures.
- Minimum 1 year of relevant work experience with increasing responsibility in data management with knowledge of 1 or more therapeutic areas.
- Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.
- Demonstrated ability to work in a team environment and collaborate with peers.
- Demonstrated interpersonal skills.
- Good oral and written communication skills.