Tanner and Associates is recruiting a Principal Clinical System Programmer to be based in Southern California. Please contact me for more information.
Leads the design, development, validation, implementation, and provides ongoing support of electronic systems e.g., Electronic Data Capture (EDC), reporting/business intelligence tools (e.g., Business Objects, Spotfire) and programs (e.g., PL/SQL) used in Clinical Research and Development studies. The responsibilities include:
- Analyze Clinical Study design requirements against third party system specifications to support the implementation of electronic systems (e.g., electronic diaries) used in Clinical studies.
- Assist in the validation of electronic systems and programs.
- Works with Clinical Data Management, Clinical Programming, Statistical Programming, Biostatistics, and the Clinical Research functions to analyze and implement clinical information technology solutions.
- Responsible for peer review and maintenance of database systems and tools to support Global Development activities.
- Provide leadership and content expertise for programming activities in support of Global Development to effectively manage data capture, review and database lock activities
- Assist with the role which includes Definition, Capture and Delivery of Clinical Study Data. Peer review of deliverables.
- Responsible for maintenance of Global Libraries and ensuring their synchronization with department standards
- Responsible for participation in the identification, evaluation, recommendation, implementation and management of Clinical Information technology solutions to support Clinical study database activities .
- Contribute to standardization of data capture, processing and reporting through traditional and innovative electronic solutions.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines .
- Degree or equivalent experience in Computer Science, Life Science or related field
- Previous experience of leading eCRF builds within a clinical programming organization, preferably within a medium-large Pharma or CRO.
- Previous experience of working with EDC systems (e.g. Phase Forward InForm Architect or Central Designer)
- Previous experience of working with Reporting/Business Intelligence Tools (e.g. Business Objects, Spotfire)
- Ability to effectively interact with and influence others without direct reporting relationships
- Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
- Knowledge of clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards
- Working knowledge of global standards related to clinical study data management activities (eCRF/CRF design, data standards, database design, coding and coding dictionaries, etc.)
- Ability to travel 5%
For more information, contact:
Tanner and Associates