Clinical BA

Bootminds; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Bootminds is seeking a Clinical Business Analyst to drive requirements for Clinical Trials and Clinical Data projects. You will gather and document business needs, collaborate with IT and QA teams, and support SDLC and CSV processes. Strong stakeholder management and EDC experience preferred.

Location: Bangalore - Hybrid arrangement with 2 days in office per week; flexibility to meet project needs.

Qualifications

• Minimum 4 years of BA experience in Clinical Trials / Clinical Data domain.
• Strong understanding of Clinical Trials, Clinical Data Management and workflows.
• Hands-on experience with EDC platforms (Medidata Rave or equivalent) - 2+ years preferred.
• Experience in BRD/FRD/ User Stories/ Functional Specs.
• Basic knowledge of SQL and database structures.

Responsibilities

• Gather business requirements and support pre-project activities including business case preparation, scope definition, objectives, and high-level requirements.
• Conduct detailed requirements gathering, analysis, and documentation with stakeholders.
• Create and maintain BRD, FRD, FS, and user stories.
• Work with business users, development, QA and external stakeholders to deliver solutions.
• Facilitate UAT planning, execution, defect tracking and sign-off.
• Coordinate with Global IT and cross-functional teams for cost-effective tech solutions.
• Develop training materials and provide user support during implementation.

Skills

Requirements Gathering

Gap Analysis

Functional Documentation

Stakeholder Management

SDLC

UAT

Excellent Communication

Data Understanding

SQL Basics

Excel Proficiency

Tools

Medidata Rave

Oracle SQL

JIRA

Confluence

Microsoft Excel

Job description

Clinical BA

Business Analyst ? Clinical Trials / Clinical Data

Key Responsibilities

• Gather business requirements and support pre-project activities including business case preparation, scope definition, objectives, and high‑level requirements.
• Perform detailed requirements gathering, analysis, and documentation while collaborating closely with business stakeholders.
• Conduct Gap Analysis and recommend appropriate business solutions.
• Create and maintain Business Requirement Documents (BRD), Functional Requirement Documents (FRD), Functional Specifications (FS), User Stories, and related documentation.
• Work closely with business users, development teams, QA teams, and external stakeholders to ensure successful solution delivery.
• Facilitate User Acceptance Testing (UAT), including planning, execution, defect tracking, and sign‑off.
• Resolve conflicting business requirements and drive consensus among stakeholders.
• Support SDLC and Computer System Validation (CSV) processes where applicable.
• Collaborate with development teams to ensure business requirements are accurately translated into functional solutions.
• Assist in process modelling and business process improvements.
• Review Performance Qualification (PQ) documents to ensure user requirements are adequately validated.
• Coordinate with Global IT and cross‑functional teams to deliver cost‑effective technology solutions.
• Develop training materials and provide user support during implementation.
• Provide timely project updates, issue tracking, and stakeholder communications.
• Recommend continuous process improvements and support digital transformation initiatives.
• Ensure compliance with regulatory standards and support audit readiness activities.

Requirements

• Minimum 4 years of Business Analysis experience in the Clinical Trials / Clinical Data domain.
• Strong understanding of Clinical Trials, Clinical Data Management, and clinical data workflows.
• Hands‑on experience with EDC platforms (Medidata Rave or equivalent EDC systems) (minimum 2+ years preferred).
• Strong experience in:
• Requirements Gathering
• Business Analysis
• Gap Analysis
• Functional Documentation (BRD, FRD, User Stories, Functional Specifications)
• Basic working knowledge of Oracle SQL and Database/Table Structures
• Experience creating and managing JIRA User Stories, Epics, and Backlog items
• Hands‑on experience with Confluence for documentation
• Strong working knowledge of Microsoft Excel
• Good understanding of Software Development Life Cycle (SDLC)
• Excellent communication and stakeholder management skills
• Good‑to‑Have Skills:
• Experience with:
• Data Transformation Rules
• Source‑to‑Target Mapping
• Vendor File Validation
• Knowledge of Technical and Grammatical Editing
• Experience supporting Audits and Compliance Documentation
• Exposure to Process Modelling techniques or modelling tools
• Understanding of Computer System Validation (CSV)

Work Arrangements

• Location: Bangalore (Mandatory)
• Candidates must be willing to work from the office 2 days per week from Day 1, with flexibility to work 5 days/week if business needs require.
• Hybrid ? 2 days/week from Day 1; may increase to 5 days/week based on business requirements.