Job Description

Position: Clinical Data Manager , Req#: 10802-1

Location: Irvine , CA ( Hybrid. 8 hrs shift, expected to be on site 3 days, 8:00 /9:00-5:00 pm PST).

Duration: 6+ Months Contract

Job Description:

The main function of a Clinical Data Manager -work closely with internal Data Management, supporting all data management activities for studies (to include database updates, migrations, CRF design and validation, edit checks, ongoing data review, data reconciliation, critical data review, document archival, Data lock activities, etc.

• Provide study status updates, provide metrics to the in-house data manager, interact with data management personnel on assigned activities and deliverables
• Reviews full study subjects for completeness and data accuracy
• Good communication and presentation skills

Education and Experience:

• Bachelor's Degree or equivalent
• 2-4 years of experience required

Skills: MUST-HAVES

• Medidata Rave experience, Data review, Query management, Excel Reports
• Know how to open and close queries.
• Able to run Rave reports, Architect module, PDF generator
• Draft Data management plan

Key Responsibilities:

• Evaluate data errors and collection issues; provide guidance and recommendations to the clinical team for resolution
• Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
• Lead project management activities for a cohort or project to bring clinical studies online, including conducting project team meetings, establishing and maintaining project timelines, and communicating with stakeholders.
• Maintain and develop assigned sections of Data Management deliverables, including data management plans (DMPs), training materials and user aids in compliance with regulations
• Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access database
• Participate in the development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, and participating in the development of user training.

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