1. Clinical Domain Analysis & CRA Operations

Demonstrate substantive knowledge of CRA operational models site monitoring, risk-based monitoring (RBM), visit report workflows, deviation management, and ICH-GCP compliance and apply this directly to requirements analysis and process design.

Map and interrogate end-to-end clinical trial workflows across startup, conduct, and closeout to surface inefficiencies, control gaps, and platform-process misalignments.

Work directly with CRA field operations, site management, and clinical project managers to elicit, challenge, and validate business requirements going beyond what is stated to uncover what is actually needed.

Translate regulatory expectations (FDA, EMA, ICH E6(R3)) into tangible process and system controls, ensuring traceability from regulatory requirement to operational practice.

2. Stakeholder Engagement & Management

Build credible working relationships with stakeholders across clinical operations, businesses, IT, data management, and vendor management earning trust through subject matter depth, not just facilitation.

Design and run structured elicitation sessions workshops, process walkthroughs, and system demos that produce concrete, actionable outputs rather than open-ended discussions.

Communicate with clarity and precision: the right level of technical detail for IT audiences, the right level of operational context for business users, and the right level of strategic framing for leadership.

Proactively flag scope creep, conflicting requirements, and misaligned expectations and drive resolution rather than deferring it.

3. Requirements Engineering & Documentation

Own requirements documentation from first draft to stakeholder sign-off process maps (BPMN), business process mappings, and use case narratives that are precise, unambiguous, and implementation-ready.

Demonstrate working knowledge of automation ROI quantifying the business value of replacing manual processes with automated solutions and translating that into measurable efficiency gains for clinical operations.

Maintain full requirements traceability from business need through to system configuration and test evidence, ensuring auditability for regulated clinical environments.

Write with intent: every document should tell a clear story, eliminate interpretation risk.

He or she should be able to have CRO related details in his head. Pharma side CRO industry.

Keep documentation current through the project lifecycle version-controlled, change-logged, and proactively updated when scope or design evolves.

4. Business Proposal Support & Commercial Input





Contribute substantively to business proposals and RFP responses led by the Business Development and Senior BA teams specifically drafting clinical operations process content, platform capability write-ups, and technology enablement narratives that require domain depth to get right.

Support the development of structured business cases by gathering operational data, documenting process baselines, and articulating benefit hypotheses in a format that senior stakeholders can build financial models from.

Translate CRO service capabilities and clinical IT platform features into clear, jargon-free descriptions that non-technical client audiences can evaluate bridging the gap between what delivery teams know and what proposal teams can articulate.

Ensure all proposal content you contribute is technically accurate, operationally grounded, and consistent with the requirements and process documentation maintained across active programmes.

5. Clinical IT Platforms & Systems Analysis

Demonstrate working depth not surface familiarity across the core clinical technology stack: CTMS (Veeva Vault CTMS, primary), EDC (Medidata Rave, Veeva EDC, Oracle InForm), eTMF (Veeva Vault TMF, Phlexglobal), RTSM/IRT, and Safety/PV systems.

Understand how clinical platforms are configured, not just what they do including object models, role-based access, workflow configuration, integration touchpoints, and data structures relevant to CRA operations.

Analyse system-to-system integration patterns (APIs, SFTP, HL7, EDI) and translate integration requirements into specifications that development and vendor teams can act on without repeated clarification.

Lead functional gap analysis between current-state system capabilities and target-state business requirements, producing clear gap registers with prioritised remediation options.

Define and execute UAT strategies: write test scripts mapped to acceptance criteria, coordinate business user participation, triage defects against requirements, and make sign-off recommendations based on test outcomes.

Engage directly with platform vendors and implementation partners to challenge solution designs, validate configuration decisions, and ensure delivered systems reflect agreed requirements not just vendor defaults.





Support data migration and reporting initiatives by understanding source-to-target data mappings, defining data quality rules, and specifying operational dashboards and KPIs for clinical performance monitoring.

QUALIFICATIONS & EXPERIENCE

Essential

Bachelor s degree in Life Sciences, Pharmacy, Information Systems, Computer Science, or a related discipline. Dual-domain exposure (clinical + technology) is a robust differentiator.

5 7 years of business analysis experience, with a minimum of 3 years directly embedded in CRO, pharmaceutical, or biotech clinical operations not adjacent to it.

Solid, hands-on knowledge of CRA role functions, site monitoring workflows, deviation management, and clinical trial operational lifecycles able to hold a substantive conversation with a CRA field team without a primer.

Demonstrable working depth across at least two enterprise clinical platforms (Veeva Vault CTMS, Medidata Rave, eTMF, RTSM) beyond user-level including configuration logic, data models, workflow setup, or integration points.

Proven ability to produce implementation-ready requirements documentation independently: BRDs, functional specifications, data flow diagrams, and UAT scripts that development teams can work from without back-and-forth.

Strong written communication skills with demonstrated ability to work effectively across offshore-onshore delivery models and across US/EU time zone boundaries.

Experience contributing to business proposals, business cases, or RFP content in a CRO or life sciences context particularly sections requiring clinical process or platform knowledge.

Proficiency in JIRA, Confluence, Visio or equivalent; comfortable navigating both Agile and waterfall delivery environments.

Desirable

IIBA CCBA, CBAP, or PMI-PBA certification, or active pursuit of one.

ICH-GCP certification; familiarity with 21 CFR Part 11, EU CTR 536/2014, and GCDMP data management standards.

Prior experience working across both sponsor-side and CRO-side operations giving you the ability to anticipate client expectations, not just execute internal requirements.

Exposure to clinical data standards (CDISC CDASH, SDTM) and their implications for EDC and reporting design.

Experience in Agile/SAFe delivery, including sprint planning, backlog refinement, and story writing for clinical technology projects.

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Business Analyst Techno-Functional (Hubballi)
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