The Director of Data Operations will oversee the development, programming and management of EDC clinical database and related systems. This includes Database design and build, edit check programming, data retrieval and integration, standard EDC libraries development and maintenance.
This individual will oversee the integration of related systems to study databases; external data transfers; provide study database related technical and end user support to other areas of Data Operations, Data Management, and Clinical team; liaise with external vendors for all technical issues related to clinical databases.
Managing the group of 6-9, consisting of 1 Associate Director, 1 Senior Manager, 1 Manager, and 3-6 Senior DB Analysts/consultants.
Oversee the Database Development process from Study start-up to Study Decommissioning, ensuring quality, efficiency in order to meet all department and company required timelines
Provide technical guidance to the Database Development in terms of programming, analysis, solution techniques, and approaches.
Develop/maintain standard EDC library which includes database design, edit checks programming, standard functions, and reports.
Master degree in Computer Science or related fields with at least 10 years of hands-on experience in clinical database development and support using EDC systems and IxRS systems, including 3-5 years of project management; 3-5 years experience in people management experience
Expertise knowledge of EDC systems (InForm and/or Rave), database structure, annotated eCRFs, edit checks, external data handling, medical coding, Clinical Data Management process, FDA regulations, system validation & QC methodologies.
Excellent oral and written communication skills; strong leadership skills, good organizational skills to effectively manage and guide multiple resources involved in various projects