Covance is seeking a Clinical Data Associate II for Phase II in Madison, WI. The Clinical Data Associate is responsible 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.
As the Clinical Data Associate II takes on the responsibility of training in the clinical data review process and will act as backup to the Study Data Manager
- Perform all data management tasks as appropriate to include, but not to be limited to: query generation and integration, discrepancy management; to ensure that quality standards (both internal and client) are achieved.
- May complete database close / lock / freeze checklists.
- May perform reconciliation of the clinical database against safety data, laboratory data and other third party data as appropriate. Use Normlab2 Plus and batch data load as appropriate.
- Perform CRF / eCRF review for standard Phase 2 studies.
- Review RDC / eCRF data entry conventions.
- Review clinical trial data in accordance with Data Validation Plans and raise Data Clarification Forms (DCFs) to resolve erroneous, missing, incomplete or implausible data. Update the database and associated documentation.
- May code terms that require the application of a thesaurus to standardize nomenclature; interact with other members of the department and other internal departments to ensure appropriate correct application of codes. If appropriate, use Oracle Clinical to assign Verbatim Term Assignments within the Thesaurus Management System.
- 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.
- Support the training of new staff on project specific, local and global data management processes.
- Serve as backup to the study Project Manager.
- Create iReview/interim listings for dose escalation and safety assessments as needed.
- 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).
Experience - In lieu of a degree, typically 2 years experience in related field (e.g. pharmaceutical, laboratory, data analysis) will be considered.
- 1-2 years clinical research experience in clinical data review.
- Knowledge of Oracle Clinical database is highly preferred.
- Knowledge of medical terminology and medical coding experience preferred.
- Knowledge of data management preferred.
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us. Covance is an E-Verify employer (US).
- See more at: http://hirelifescience.com/seeker_jobs.aspx?jobsID=463509&jobtitle=Clinical%20Data%20Associate%20II%20Clinical%20Data%20Coordinator