Job Description

Requirements

• Bachelors degree (or foreign equivalent degree) in Biotechnology, Computer Science, Engineering, Mathematics, Biological Science or related field with 3 to 5 years of experience, or Masters degree with 2 to 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

Responsibilities

• 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

Qualifications

Bachelors degree (or foreign equivalent degree) in Biotechnology, Computer Science, Engineering, Mathematics, Biological Science or related field with 3 to 5 years of experience, or Masters degree with 2 to 3 years of experience in Data Operations methods and processes in industry setting.

Additional Information

All your information will be kept confidential according to EEO guidelines.