Clinical Data Associate
This is a remote position.
Serve as a member of the project team with primary responsibility for co-ordinating the clinical data review, query generation / resolution and reconciliation activities to support the Data Management lead with the delivery of clinical data according to client quality and integrity specifications, project timelines and productivity targets.
Assist in the development of the project Data Management Plan, including data review guidelines /diagnostics specification and setup of the data management systems according to project requirements
Serve as back-up to Clinical Data Manager, with oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, project timelines and budgets
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 aggregate data review activities and apply proper modification / correction to the database as required.
- 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 QC data listings for internal data review or dose escalation decisions.
- Assist with creating or performing review of Study Test Plan, Study Test Report. Edit Check Specifications, Database specifications or User Acceptance Test scripts
- Modify standard templates to create study specific Data Management Plans, or eCRF completion guidelines
- 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
- Perform database extracts
- Assist in the creation of presentations for Site Initiation Visit or similar meetings
- Participate in eCRF Screen Review meetings
- Assist with the completion of Database Lock activities
- Code terms that require the application of a medical coding dictionary
- Demonstrate awareness of project schedules and the importance of hitting deadlines
- Support the training of new staff on project specific Data Management processes
- Serve as back-up to the Lead Data Manager
- Performs any other duties as assigned.
Education/Qualifications/Certifications and Licenses
- BS in Biology, Nursing, Chemistry or related field.
- Knowledge of drug development process
- Knowledge of effective clinical data management practices
- Fluent in English, both written and verbal
- In lieu of above requirement, greater than 2 years experience in related field (e.g. pharmaceutical, laboratory, data analysis) incorporating approximately one years clinical data management experience will be considered
Sthree US is acting as an Employment Business in relation to this vacancy.