RESPONSIBILITIES

• Administer and maintain Clinical Data Capture and Management System(s) in accordance with Regulatory and Merial Procedures.
• Responsible for creation and execution of studies within computerized systems for data capture and validation.
• Responsible for providing support and assistance to study directors and monitors in Clinical Operations with data capture and the management of studies in accordance with Regulatory and Merial procedures.

• Responsible for the administration and maintenance of computerized systems to manage clinical data for the department.
• Responsible for the creation of new ClinSight Capture System studies, including data entry screens and construction of the underlying data base structures.
• Responsible for the generation and coordination of all documentation and tasks relating to data quality including Data Quality and Data Validation Plans, Data capture validation, Data file management (computed or manual captures, consistency checks, query generation, resolution and tracking, collecting metrics, validated formatting and customized transfers for analysis and reporting to Biostatisticians, Study Directors/Monitors or other functions)
• Responsible for creation of data capture forms and data validation using other computerized systems i.e. Excel, Teleform, etc.
• Interacts and provides support to QA and Biometrics as needed for their access to the data management systems.
• Support the development and maintenance of an efficient and harmonized approach to data mangement activities in Clinical Operations.
• Maintain data management skills, awareness of GLP’s and GCP’s and 21 CFR Part 11 to the high standards expected by Merial. Participate in staff training programs to raise awareness of GLP’s & GCP’s, and data management of Clinical Operations personnel.
• Provides support (training, information, development of data and procedures) to the Veterinary Scientists in the group.
• Support Veterinary Scientists in the conduct of GCP/GLP studies in particular by the management of data capture and data checks using computerized systems.
• Ensures appropriate training of Clinical Operations and other personnel to ensure adequate knowledge and uniform deployment of data collection systems.

REQUIREMENTS

• BS with a degree in Computer Science or a Science-related field
• Minimum of 2 years of Clinical Data Management Experience and 5 years of computer/ scientific experience
• Proficiency in Relational Databases and Microsoft Office required.
• Experience in a science or health-related field is a plus.
• Knowledge of GLP and GCP regulations as well as Good Clinical Data Management Practices and 21CFR Part 21 is a plus.
• Experience with an Oracle Database and Knowledge of SQL and Visual Basic is a plus
• Excellent verbal and written communication skills.
• Ability to work effectively and efficiently as a team member and under pressure is essential

HOW TO APPLY