Role: Sr BA to join our Clinical Data Management team. This is a strategic role that goes beyond traditional data management. You will serve as the critical bridge between our clinical operations, data management, and technology teams, ensuring that our clinical trial systems and processes are aligned with business goals and regulatory standards.

In this role, you will leverage your deep understanding of the clinical trial lifecycle to facilitate requirements workshops, document functional specifications, and drive process improvements that enhance the efficiency and quality of our clinical data workflows.

Key Responsibilities

- Business Analysis & Requirements Engineering (Primary Focus)

Facilitate Workshops: Lead and facilitate business requirements workshops with cross-functional stakeholders including Clinical Data Managers, Biostatisticians, Clinical Operations, Regulatory, and IT teams to define project scope and objectives.

Requirements Elicitation: Elicit, analyse, and validate business requirements, translating complex clinical needs into transparent, actionable functional and technical requirements.

Documentation: Author and maintain comprehensive Business Requirement Documents (BRD), Functional Requirement Specifications (FRS), User Stories, Acceptance Criteria, and Requirements Traceability Matrix (RTM).

Process Mapping: Analyze and map current and future-state business processes (clinical data workflows, EDC data flows, study setup procedures) to identify gaps and recommend improvements.

- Clinical Domain & Stakeholder Management

Clinical Expertise: Apply strong knowledge of Clinical Trials (Phases I-IV), Clinical Data Management (CDM), and ICH-GCP guidelines to guide project decisions.

Stakeholder Collaboration: Act as the primary point of contact for business stakeholders,



managing expectations and ensuring alignment between business needs and solution delivery.

Vendor & Cross-functional Coordination: Coordinate with external vendors, CROs, and internal teams (e.g., Data Engineering, QA, Programming) to ensure seamless integration and delivery of clinical data solutions.

- Project Lifecycle & Support

Agile/Scrum Delivery: Participate in all Agile ceremonies (Sprint Planning, Backlog Refinement, Demos) and manage requirements using tools like Jira and Confluence.

UAT & Validation: Plan and execute User Acceptance Testing (UAT), oversee defect tracking, and coordinate business sign-off to ensure solution quality and compliance.

Data Analysis & Validation: Support data mapping, source-to-target mapping, schema validation, and data validation activities to ensure the integrity and traceability of clinical trial data.

Required Qualifications & Experience

Education

Bachelor's or Masters degree in Life Sciences, Biotechnology, Pharmacy, Health Informatics, or a related field. An MBA is a plus.

Core Experience

6 to 10 years of overall experience, with a minimum of 4+ years in a formal Business Analyst role within the Clinical Trials, Clinical Data Management, or Healthcare IT domain.

Clinical Domain Expertise

Deep understanding of the clinical study setup process, clinical data management operations, and the drug development lifecycle. Strong knowledge of CDISC standards (SDTM, ADaM) , ICH-GCP, and 21 CFR Part 11 is highly desirable.

BA & Documentation

Proven track record of facilitating business requirements workshops and authoring BRDs, FRDs, User Stories, and Process Flows.

Tools & Methodologies

Proficiency in Jira, Confluence, and MS Excel. Experience with Agile/Scrum methodologies and the full SDLC.

Technical Acumen

Working knowledge of EDC systems (e.g., Rave, Veeva Vault, InForm) . Familiarity with SQL for data validation and analysis is a strong plus.

📌 Urgently Hiring - Senior Clinical Business Analyst (Bengaluru)
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📍 Bengaluru