Clinical Data Analyst
W-2 Contract Role
Duration: 12 Months
Location: Irvine, CA 92606
Pay Rate: $43.74/hour
Position Summary
The Clinical Data Analyst will lead and support clinical data management activities throughout the clinical study lifecycle, including study start-up, conduct, closeout, and database lock. This role is responsible for ensuring accurate data collection, data quality, regulatory compliance, and effective project coordination across clinical studies.
Key Responsibilities
- Define and specify clinical data collection requirements, including:
- eCRFs/CRFs
- Edit checks
- External data collection requirements
- Utilize Global Library standards and coordinate User Acceptance Testing (UAT), including test scripts and checklists.
- Review, evaluate, and resolve data discrepancies and collection issues.
- Provide recommendations and guidance to clinical teams regarding data quality and issue resolution.
- Lead data management project activities, including:
- Clinical study meetings
- Project timeline management
- Stakeholder communications
- Develop and maintain Clinical Data Management documentation, including:
- Data Management Plans (DMPs)
- Training materials
- User guides and job aids
- Ensure compliance with applicable regulations and company procedures.
- Perform user access management and internal/external data reconciliation activities.
- Manage and maintain Trial Master File (TMF) documentation and filing requirements.
- Participate in the review and revision of SOPs, work instructions, and related documentation.
- Support user training initiatives and continuous process improvement efforts.
Required Qualifications
- Bachelor's Degree or equivalent combination of education and experience.
- 2 to 4 years of Clinical Data Management or Clinical Data Analyst experience.
- Experience working with Electronic Data Capture (EDC) systems, including:
- Medidata RAVE Classic
- Medidata RAVE EDC (new platform)
- Experience supporting clinical trials and clinical study data management activities.
- Proficiency in Microsoft Office Suite.
Preferred Qualifications
- Experience using AI tools such as Microsoft Copilot or Claude to support clinical trial and data management activities.
- Familiarity with clinical trial documentation processes and TMF management.
Required Skills
- Clinical Data Management (CDM)
- Electronic Data Capture (EDC)
- Medidata RAVE (Classic and New RAVE)
- User Acceptance Testing (UAT)
- Data Reconciliation
- Database Lock Activities
- Trial Master File (TMF)
- SOP Documentation and Training
- Strong Written and Verbal Communication
- Critical Thinking and Problem-Solving
- Project Coordination and Stakeholder Management
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.