Position: Analyst, Clinical Data Management / 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 analyst is to create moderately complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess the need for training and provide basic recommendations to improve data status during study conduct.

Education and Experience:

• Bachelor's Degree or equivalent
• 2-4 years of experience required
• Medidata Rave EDC, database updates/migrations, data review, query management, etc.
• Data management experience, support lead on a study, Medidata RAV EDC database experience
• Experience with EDC (Electronic Data Capture) systems required
• Good computer skills in Microsoft Office Suite
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills

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 (10%)
• Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access the data database
• Participate in the 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.

More on this role:

• What does your group do? Manage/Support Clinical Data management activities for a study.
• Does your team use any specific technology/software you want us to look out for? Experience with Electronic Data Capture (EDC) platforms (medidata Rave, Oracle Clinical), data programming tools and/ data reviewing tools (SAS)
• What does the ideal candidate need to possess to be successful in this role? Works closely with internal Data Management supporting all data management activities for studies (to include database setup, CRF design and validation, edit checks, ongoing data review, data reconciliation, critical data review, document archival, Data lock activities etc. Reports status, 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. Good communication and presentation skills
• What will a typical workday look like? 8 hrs shift, expected to be on site 3 days 8:00 /9:00-5:00 pm PST
• What will the work schedule be? Can any overtime be expected? How many days onsite? No, Hybrid model- on-site 3 days a week
• Will there be any travel involved? No. (only to onsite for work)
• What are your top 3 required technical skills? Must haves? Medidata Rave experience, Data review, Query management, Excel, Reports
• What are nice-to-have skills? Communication skills, lead/ co-lead a study
• Is there anything that would automatically disqualify a candidate? 1. Not having Medidata RAVE EDC experience 2. Clinical Data management experience( as a support lead)