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.
Work with management and senior DM personnel to implement technical solutions and resolve issues.
Requirements
Minimum BS in a scientific or health related field or the equivalent in years of experience.
Minimum 5 years in Clinical Data Management.
Minimum 1 year acting as a Lead Data Manager on one or multiple projects (study start up through database lock).
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
Pharmaceutical Manufacturing
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