Senior Business Systems Analyst
1 week ago
We are seeking a highly skilled Clinical Trial Management Expert to join our team at Infosys. As a key member of our organization, you will be responsible for analyzing business requirements and translating them into well-formed technical and system requirements.
Key Responsibilities- Perform business requirement analysis and use case modeling from a business analysis/consulting standpoint.
- Develop and maintain technical and system requirements for clinical trial management processes.
- Collaborate with cross-functional teams to ensure seamless integration of clinical trial management processes.
- Provide technical expertise and guidance on clinical data management processes and related applications.
- Develop and maintain knowledge of clinical data warehouse and related technologies.
- Bachelor's degree or foreign equivalent required from an accredited institution.
- At least 4 years of Information Technology experience.
- At least 4-8 Years' experience in one or more of the following skills:
- End-end Clinical trial management process and related applications.
- Knowledge of Clinical Data Management processes with knowledge of Clinical Datawarehouse.
- Experience in Clinical data management applications such as OC/RDC/TMS.
- Experience on clinical reporting (internal, FDA) during study start to closeout phases.
- Experience in Computer systems Validation activities.
- Familiarity with Good Clinical Practices, Good Documentation practices, Clinical Trial Quality & Compliance.
- Good Knowledge of Study life cycle activities (Study Protocols /study design for IRT and EDC Studies), various study milestones, clinical trial regulatory reports and other metrics reports at study level /site level.
- Basic- Must be able to translate business requirements into well-formed technical and system requirements.
- Basic Experience with modeling business processes, data flows, and workflow processes depicting relationships between Clinical data entities.
- Agile – Scrum experience.
- Strong business consulting skills associated with complex IT system implementation spanning over 12-18 months.
- Strong oral & written communication skills, Business stakeholder management.
- Experience and desire to work in a management consulting environment that requires regular travel.
- A basic knowledge writing custom queries in SQL or PL/SQL is needed for data extraction and validation.
- Experience in the full System Development Life Cycle (SDLC) on a variety of technologies and platforms preferably in pharma IT space.
- Experience with project management.
- Planning and Co-ordination skills.
- Experience and desire to work in a management consulting environment that requires regular travel.
- Experience and desire to work in a Global delivery environment.
- Ability to write design documents and walk the audience through the design.
- Able to estimate for the end to end delivery of Integration projects.
- Able to work on technical aspects and help tackle complex items including Integration.
We are unable to sponsor at this time. U.S. citizens and those authorized to work in the U.S. are encouraged to apply.
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