Job
Description
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
