Location
Secunderabad | India
Job description
- GCH Bridge/ IMDRF Technical Lead Role: Technical lead for complaint handling/IMDRF bridge, which sends potential complaints from clinical trials to complaint handling system and sends adverse events and device deficiencies to IMDRF coding system.
- There are several releases throughout the year , which consist of adding new clinical studies , updates to data for existing studies and o ccasionally , updates to the overall bridge logic
- This role is responsible for ensuring the accuracy and consistency of the changes in each release. A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Engages with business leaders to understand how strategies and data-driven changes can improve efficiencies and add value.
- Work with data sets to define use cases to improve products, processes and/or services.
- Collaborates with Business Relationship Manager (BRM), business stakeholders and IT Product Owners / Managers to develop business requirements for product or system changes.
- Drives business agenda during solution delivery process.
- Functional Skills: Ability to analyze data and trends in order to develop recommendations to solve business problems.
- Additional Skills: Problem Solving, Detail Oriented, Cross-Functional Collaboration, Customer Service, Process Improvement, Communication.
- Technology: Understanding of systems, software and technological concepts, Familiarity with data analysis tools and data modeling methodologies.
Summary of responsibilities:
- Participate in requirements meetings, and provide input/feedback for requirements as needed, to ensure consistency with bridge logic and standards .
- Create data mapping document for new studies and updates. Design the standard/custom profiles such that studies can reuse the mappings. Conduct impact assessment to e nsure new study design does not impact existing studies or bridge logic. Review document with developer to ensure understanding
- Direct mapping developer as needed during development. Answer questions, make decisions about how to map data as needed. Ensure BA is aware of changes and how that impacts the data that is sent via the bridge.
- Conduct code review for mapping development. Ensure standards are met . Review and update development standards as needed
- Help write the test conditions to ensure all data is tested thoroughly, for new study as well as regression based on updates to existing functionality as needed.
- Review test scripts to ensure everything is being tested thoroughly.
- Help triage and/or resolve defects identified during testing.
- Help identify/provide resolution for production issues escalated by support team.
- Point person for technical questions regarding the bridge.
- Update bridge design documents, direct design discussions and development for any bridge logic changes
- As needed, c omplete development for bridge logic and/or study mapping - ( this is more of a good to have, not required ) .
- Collaborat e with clinical development partners in designing improved bridge interface model which can be leveraged by both GCH bridge and safety reports.
- Identify areas of improvement for efficiency and standards for the bridge
Must Have: Minimum Requirements
- Requires mastery of PL/SQL and full knowledge of industry practices, typically obtained through advanced education combined with experience.
- May have broad knowledge of project management.
- Requires 7+ years of experience with a bachelor s degree or 5+ years of experience with an advanced degree or 12+ years of experience with a High School Diploma or equivalent.
- Experience in the following application s is highly desired - Oracle Clinical, Medidata RAVE, Life Sciences Hub .
- Experience with data integrations and sending data from one system to another
- Experience with troubleshooting and problem solving in complex environments , multiple systems and multiple teams
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