Clinical Data Manager
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, the Clinical Data Manager to complete all Data Management tasks from study start-up to database lock for assigned studies according to the applicable SOPs and study-specific procedures. Lead small to medium size studies. Effectively interact with sponsors.
Here’s What You’ll Do:
- Act as the Lead Data Manager for one or multiple studies.
- Complete Data Management tasks for assigned studies under minimal supervision according to the study contract and applicable SOPs.
- Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures.
- Work with database programmers to design (e)CRFs and edit checks in EDC system.
- Create test data for User Acceptance Testing (UAT).Perform and document database UAT.
- Receive, integrate, and reconcile electronic data.
- Perform data review via listings and EDC system, issue and resolve queries.
- Manage queries to ensure data completeness and integrity.
- Assist with data listing design for data review.
- Perform SAE reconciliation.
- Perform pre-lock and data lock tasks.
- Participate in client and team meetings as required.
- Design, generate, and review status metric reports as needed.
- Perform archiving of study databases and related documents
- Provide input to timelines to ensure timely completion of assigned tasks.
- Provide regular status updates and keep the team and management informed of any changes.
- Organize and file study documentation.
Here’s What You’ll Bring to the Table:
- Minimum BS in a scientific or health related field or the equivalent in years of experience.
- Minimum 5 years in Clinical Data Management.
- Expertise with EDC systems, such as Medidata Rave, InForm, IBM Clinical, Veeva EDC or Medrio.
- Excellent communication and time management skills.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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