Director, Clinical Data Management

Description

• Responsible for managing, planning and coordinating the activities of the Data Management group
• Responsible for ensuring the data collected is error free and meets the requirements of the study sponsor and internal Novum quality standards.
• Ensure that the Data Management group is aligned with business objectives as well as in compliance with all FDA requirements.
• Work closely with management to prepare and execute data management plans to manage projects from beginning to end.
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
• Work closely with Clinical Trials Division and Statisticians and other staff as appropriate to develop CRF's to ensure the information required for statistical analysis is present.
• Co-ordinate with database programmers/QA to create and validate database design and edit check specifications.
• Oversee hiring, daily management, training and development of data management staff.
• Oversee coding of safety data using industry standard coding directions.
• Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data.
• Develop and update SOP's associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.
• Assist with the validation of the statistical output for the final report.
• Other duties as assigned.

• At least 7 years in a clinical research data handling environment with relevant practical experience in protocol review/CRF design, clinical study databases and data management.
• At least 3 years experience managing a data management group. Experience in a service environment would be preferable.
• Working knowledge of Word Processing software, Microsoft Project, e-mail software, Microsoft Access, and Microsoft Excel. Practical experience with SQL and SAS required.
• Excellent organizational skills with a demonstrated ability to manage staff, projects and resources to meet timelines and budgets.
• Effective problem solving, collaboration and teamwork skills.
• Ability to travel up to 20% as needed.