Clinical Data Manager
1 week ago
Position Title – Sr. Clinical Data Manager
Location – Aliso Viejo
Shift – M-F 8-5
Pay Rate – $60 an Hour
Contract role covering a LOA through July 2025 could extend
Job Description:
The Senior Clinical Data Manager is responsible for study Data Management activities from study start up to close out. The Senior Clinical Data Manager creates the data cleaning strategy and leads the data cleaning efforts supporting Clinical Studies. The Senior Clinical Data Manager works in coordination with Data Management, Biostatistics and Clinical Operations teams to develop standard operating processes in support of clinical research.
Project Management:
Represent Data Management in study team meetings, providing data status metrics and providing guidance on issues related to data management.
Responsible for study Data Management activities from study start up to close out.
Author Data Management timelines for assigned studies.
Manage performance, quality, and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders).
Data Management Documents:
Author Data Management documentation (e.g. Data Management Plans, Data Review Guidelines and eCRF Completion Guidelines, and Study Timelines, etc.)
Author Data Management training materials used for Investigator Meetings, in-house personnel, and site staff.
Maintain Data Management project documentation including vendor files in an audit- ready manner.
Assist the Lead Clinical Programmers with the creation and maintenance of Data Transfer Agreements.
Experience Requirements
- BS or higher in biological science, nursing or other health-related discipline preferred. Skills : Minimum of 5 years of experience working in clinical data management, preferably in the pharmaceutical or medical device industry.
- Understanding of clinical trial process. Understanding of FDA/ICH guidelines and industry/technology standard practices. Understanding of Good Clinical Data Management Practices (GCDMP) and other regulatory guidelines specific to data management. Hands-on working knowledge of Electronic Data Capture (EDC) systems (e.g. MedNet, Rave, Veeva Vault EDC, etc.).
- Hands-on ability to review data and ability to use various reporting and analytics tools. Multi-tasking, problem-solving and verbal and written communication skills essential. Project Management experience Experience writing Data Management documentation (e.g. Data Management Plans, Data Review Guidelines, and eCRF Completion Guidelines, and Study Timelines, etc.)
- Excellent verbal and written communication skills. Ability to work well with others. Knowledge of CDISC Standards (CDASH, SDTM). Ability to effectively manage a variety of data management tasks for multiple clinical studies and different stages of activity.
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