The Director of Data Operations Database Development in Integrated Oncology Data Services (IODS), Oncology Business Group (OBG), will oversee the development, programming and management of EDC clinical database and related systems such as IxRS and other vendors systems. This includes, but is not limited to: Database design and build, edit check programming, data retrieval and integration, standard EDC libraries development and maintenance. 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 within Oncology Business Group.
The Director of Data Operations will oversee the Database Development group and IxRS systems group within IODS, OBG. Reporting to the Director of Data Operations is the Associate Director of Project Management and Budget for IODS, the Manager of Database Operations Group, the Senior Manager of IxRS Group, and 3 Clinical DB Programmer Analyst.
Managing the group of 6-9, consisting of 1 Associate Director, 1 Senior Manager, 1 Manager, and 3-6 Senior DB Analysts/consultants supporting EDC and IxRS systems.
Assist the Executive Director of Data Operations in establishing the strategy and standards to achieve departmental /company goals.
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 and IxRS system in terms of programming, analysis, solution techniques, and approaches.
Develop/maintain Oncology standard EDC library which includes database design, edit checks programming, standard functions, and reports.
Proactively identify and track Oncology Data Management need in terms of database development, and propose/implement solutions.
Coordinate the activities related to trouble shooting, end user support, and provide resolutions in a timely manner.
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
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