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.
Potential to assist in development of project Data Management Plan, including
data review guidelines / set-up of the data management systems according to project requirements.
Potential to serve as the operational data management leader – as a Lead Data Reviewer, on small projects with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, project timelines and budgets.
- Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
- Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
- Generate, resolve and track queries to address problematic data identified during data review activities
- Perform 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.
- Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans, Perform Data review utilizing all applicable documents such as protocols, CRFs (or eCRFs and eDiary) etc.
- Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
- Assist in the review of the database design and annotate the CRF (eCRF) according to the specifications.
- Create and assist in the data review guidelines, make sure to be consistent with the clinical data model, and CRF/eCRF completion / monitoring conventions.
- Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
- May assist with the Lead Data Manager or Lead Data Reviewer to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary.
- Knowledge of Data Management tools, systems, and processes.
- Ensures service and quality, meet agreed upon specifications per the DMP and scope of work in the budget.
- Inform Lead Data Reviewer of overages in budgeted units and assist in Change Order Log process, if applicable.
- Perform quality control on data management activities as appropriate to include, but not be limited to all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved.
- Support and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team, as appropriate.
- Mentor / Coach in training of project staff on project-specific, global, standardized data management processes.
- Performs other related duties as assigned by management