Job Description:
Must-Have Skillset
- 5-7 years of experience as BA with 4 years of minimum experience in Clinical Trial Domain / Clinical Data as BA
- Strong experience in clinical trials, EDC/RAVE Data, and clinical data platforms
- Expertise in requirements gathering, gap analysis, and functional documentation
- Basic understanding and hands-on experience on Oracle SQL, Table Structure Basics.
- Proficiency in tools like Excel, JIRA, Confluence
- Knowledge and hands-on experience on Oracle SQL, Table Structure Basics.
- Strong knowledge on SDLC
Good-to-Have Skillset
- Experience with data transformation rules, source-to-target mapping, and vendor file validation
- Knowledge of technical and grammatical editing
- Familiarity with audit support and compliance documentation
- Ability to learn and use modelling languages when / where required
Key Responsibilities –
- Gathering of initial Business Case requirements & other pre-project activities (e.g., high-level requirements, project scope, objectives)
- Perform requirements gathering and analysis to provide high quality and detailed requirements, ensuring the closest involvement with, and agreement from, the user community
- Facilitate UAT planning, execution, and documentation for study rollouts
- Collaborate with internal teams and external clients to resolve data issues
- Resolve conflicting end-user requirements
- Follow IQVIA Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) procedures, as appropriate
- Collaborate with the Lead User, or delegated member of the applicable business group, to create a User Requirements Specification document
- Collaborate with the Development group to create a Functional Specification (FS) document
- Assist with process modelling to clarify business requirements, and to enhance or re-engineer business processes, prior to, or in parallel with, solution design and implementation, as necessary
- As needed, assist with the review of the Performance Qualification (PQ) document(s) prior to authorization and execution, to ensure that it incorporates previously captured requirements, and includes tests or test steps that explicitly address each identified user requirement
- Collaborate with Global IT Solutions functional groups by adhering to established processes to ensure that business requirements are delivered through successful project implementation of optimal, cost-effective solutions
- Collaborate with developers and testers to ensure adherence to business requirements and UI design specifications
- Develop training and support programs for global technology and process implementations, as needed
- Provide timely updates, issue summaries, and follow-ups to stakeholders
- Recommend process improvements and contribute to digital transformation initiatives
- Ensure compliance with regulatory standards and support audit readiness
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- BE, bachelor's or master's Degree, Clinical Information Management or equivalent qualifications (B. Pharma & M. Pharma).
