Job Description

Job ID: 619158

Our client, a leading Medical Device company, is seeking a junior level Clinical Data Reviewer who has experience with opening/closing queries, data review (utilizing Medidata Rave) and running Excel reports. This position is perfect for someone who has about 2-4 years of experience in either the CRO, Biotech or Medical Device industry supporting Lead CDM's (any more than 4 years of experience will be considered overqualified for the role). See additional details below!

***Please Note: This is a hybrid onsite position in Irvine, CA - please only apply if you are either local to the area or plan to relocate on your own***

Top Skills Needed:

• 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 Plans (DMPs)

Summary:

• The main function of a Clinical Data Manager -Works 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, provides metrics to in-house data manager, interactions with data management personnel on assigned activities and deliverables
• Reviews full study subjects for completeness and data accuracy
• Evaluate data errors and collection issues; provide guidance and recommendations to 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 on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
• Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations (10%)
• Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base
• Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.
• Medidata Rave experience, Data review , Query management, Excel Reports
• Know how to open and close queries. (MUST HAVE) (We had too candidates who only assisted with querys but never knew how to open/close on their own)
• Able to run Rave reports, Architect module, PDF generator
• Draft Data Management Plans (DMPs)

Requirements:

• Able to work onsite (hybrid) in Irvine, CA (we do not provide relocation assistance)
• 2-4 years of experience as a Clinical Data Coordinator/Reviewer (no more than 4 years)

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