Responsible for providing support for clinical studies within designated IxRS systems according to Oncology’s processes and standards. Accountable for providing IxRS support in study setup, documentation review, and implementation of the clinical studies for UAT and production releases. The incumbent responsibilities include IxRS integration, study maintenance, user support, testing, collaboration with study team members – vendor support, and decommissioning of study IxRS. Provides technical expertise to the clinical team members and to the developers in the areas of clinical database design, and related technical programming based on Protocol design.
Bachelor’s degree (or foreign equivalent degree) in Biotechnology, Computer Science, Engineering, Mathematics, Biological Science or related field with 3 -5 years of experience, or Master’s degree with 2 -3 years of experience in Data Operations methods and processes in industry setting.
Knowledge of the IVRS/IWRS/IRT systems, Clinical Data Management Systems, InForm 6.x, Central Designer 2.x, Central Coding, relational Databases, Oracle, SQL, COGNOS, MedDRA, WHODRUG dictionaries, CDISC, and CDASH is a plus
• Provides technical expertise to the clinical study team members in the areas of IxRS design for Oncology studies, and related documents.
• Draft study specific IxRS UAT Scripts and maintain Global/Standard IxRS Scripts Library.
• Ensure that all the study designs follow the IxRS standards.
• Provide support for IxRS set up for Oncology studies and related standards, user support & management.
• Ensure IRT processes are compliant with GCP & GMP guidelines and principles, 21CFR Part 11, and applicable regulations.
• Develop IxRS External data transfer specifications to the vendor for data transfer and test for accuracy.
• Monitor and collaborate with the vendor for trial deployment, coordinate postproduction changes, IxRS decommissioning, user & and submission related support.
• Develop standard and Ad-hoc listings to support Data Management and other clinical areas related to EDC studies for data cleaning, data reviewing, and trial monitoring functions
Source: Job Diva – Job Listing