Accountabilities
- Collaborate with Business stakeholders - hold requirements elicitation sessions as well as backlog refinement sessions
- Document business requirements for the technical team (user stories with acceptance criteria)
- Work with business and technical staff to prioritize requirements that need to be delivered for each sprint
- Collaborate with the technical team to understand operational challenges
- Assist Release Manager and Product BA in roadmap and release planning
- Assist in coordination and supervision of the release process in terms of compliance artifacts - gather stories approvals, support Business stakeholders with BCR, BCCF, etc.
- Document BA-related processes and information in Confluence (ways of working, Jira-related information, etc.)
- Assist system owners in conducting help clinics and feedback sessions for end users to improve the overall quality of the platform
- Assist in the preparation of business cases to aid in decisions on system implementation
- Assist with system testing activities by creating/reviewing test cases and providing requirement clarifications to the testing team
- Contribute to regression testing activities by providing feedback on the test suite to ensure necessary functional requirements are covered and enhanced in every release
- Execute regression test cases independently or in association with the testing team
- Assist in creating or create UAT test cases that cover essential business scenarios/use cases
- Train testers from the business side on the functional aspects of the application
- Clarify any functional queries that may arise during testing activities
- Follow up with UAT testers, QM s, and all relevant stakeholders to get sign-off on UAT
- Proactively drive identification of opportunities to be leveraged in solutions delivered
Essential Skills/Experience
- Experience in Monitoring and Visualization Analytics Applications
- Experience in clinical data management, clinical data analytics, and visualization, clinical data programming experience
- Knowledge of the drug development process and clinical trial execution as they relate to data collection, management, analytics, and reporting
- Excellent understanding of common industry-standard business practices as related to clinical trials (study setup, clinical operations, data management, and reporting)
- Excellent knowledge of software development, testing processes, and methodologies and undeniable passion for business and system analysis
- Excellent written, verbal communication, and relationship management skills
- Able to work independently with minimum supervision
- Scrum Master Certification, Knowledge of Agile/Scrum methodology
- Experience working with JIRA, Confluence
- Experience of change management process in GxP validated SaaS environment
Desirable Skills/Experience
- Self-motivation and an ability to contribute to rapidly evolving programs
- Working knowledge of CDASH, SDTM, ADaM, and CDISC controlled Terminology in the context of clinical data
- Experience in EDC (such as RAVE, Inform, Veeva) and Data Management
- Experience with and knowledge of tools that can help make software delivery and testing more effective
- Worked in a global organization where stakeholders and project team members are geographically dispersed
