Clinical Business Analyst (Clinical BA)

5-7 Years

Early Applicant

Job Description

Experience & Availability

Overall Experience Required: 5-7 Years
Relevant Experience: Minimum 4+ Years as Business Analyst in Clinical Trials / Clinical Data Domain
Notice Period: Immediate Joiners or Serving Notice Period

Interview Details

Interview Process

Top Skills

Must-Have Skillset

5-7 years of experience as a Business Analyst.
Minimum 4 years of experience in Clinical Trial or Clinical Data domain.
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 with Oracle SQL and table structures.
Strong proficiency in Excel, JIRA, and Confluence.
Good understanding of Software Development Life Cycle (SDLC).
Ability to work with stakeholders and translate business needs into functional requirements.

Good-to-Have Skillset

Key Responsibilities

Gather business case requirements and support pre-project activities.
Conduct requirements elicitation, analysis, and documentation.
Perform gap analysis and manage requirement traceability.
Facilitate UAT planning, execution, and documentation.
Collaborate with internal teams and external clients to resolve data-related issues.
Resolve conflicting business and user requirements.
Follow IQVIA SDLC and Computer System Validation (CSV) procedures.
Create and maintain User Requirement Specifications (URS).
Work with development teams to prepare Functional Specification (FS) documents.
Support process modeling and business process improvements.
Review Performance Qualification (PQ) documents to ensure requirement coverage.
Collaborate with Global IT Solutions teams for successful project implementations.
Work closely with developers and testers to ensure business requirements are met.
Develop training and support materials when required.
Provide regular status updates, issue tracking, and stakeholder communication.
Support digital transformation initiatives and continuous process improvement.
Ensure compliance with regulatory requirements and audit readiness activities.

Minimum Required Education

Recruiter Focus Areas

Hands-on experience in Clinical Trial and Clinical Data Management projects.
Strong exposure to EDC tools, especially Medidata Rave.
Experience creating BRD, FRD, URS, FS, and UAT documentation.
Strong stakeholder management and requirement gathering skills.
Knowledge of Oracle SQL and clinical data structures.
Experience working in regulated environments with compliance and audit requirements.
Excellent communication and client-facing capabilities.