SkillSet: drug regulatory affairs , clinical trials , pharmacovigilance, pharmaceutical analysis , pharma d .
Ensures the accuracy and consistency of clinical databases by:
- Reviewing data and identifying errors/inconsistencies
- The Trainee Clinical Data Coordinator maintains essential study documents for clinical research studies and enters data onto Case Report Forms and ensures study compliance.
- Prepares reports and assists with statistical analysis.
- Records accurate data by completing paper or electronic CRFs.
- Under Clinical Data Management Process tasks are assigned to 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
- Perform and document database and report 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
- Provide input to timelines to ensure timely completion of assigned tasks
- Provide regular status updates, keep the team and management informed of any changes
- Organize and file study documentation
- Work with management and senior Data Managment personnel to implement technical solutions and resolve issues
- Adhere to all standard operating procedures of Perceptive Informatics.
- Adhere to applicable regulatory requirements (21CFR Part 11, GCP, etc.)
PREFERENCES FOR A CANDIDATE : An ability to cultivate relationships and communicate effectively, both verbally and in writing, is essential.Industry
: Pharma / BiotechFunctional Area
: Customer Service (Domestic),Operations Management / Process AnalysisCompany Type
: ConsultantJob Location