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Job Title: Business Consultant – Clinical Operations & Technology Location: (US, UK, India, Japan) Client: Leading Global Pharmaceutical Company Employer: Sonata Software Experience Required: 8+ years in Life Sciences / Pharma domain Employment Type: (Full-Time) Role Overview: Sonata Software is seeking a seasoned Business Consultant with deep domain expertise in Clinical Trials and Clinical Operations , coupled with a strong understanding of clinical technology systems. This individual will play a pivotal role in bridging business needs with technological solutions for a major pharmaceutical client. As a trusted partner to Clinical Operations stakeholders, you will be responsible for gathering, analyzing, and documenting business requirements, translating them into detailed functional specifications, and collaborating with cross-functional teams to ensure seamless implementation. Key Responsibilities: Requirement Gathering & Analysis Engage with Clinical Operations and cross-functional stakeholders to elicit and document business needs and pain points. Translate business requirements into clear, actionable Functional Specification Documents (FSDs) . Develop Requirements Traceability Matrices (RTMs) to ensure alignment and accountability throughout the project lifecycle. Process Improvement & Thought Leadership Analyze existing clinical processes and workflows; identify areas for optimization. Recommend and design process improvements leveraging industry best practices and regulatory standards (e.g., ICH-GCP, CDISC, eTMF, CTMS). Provide thought leadership on innovative use of technology in Clinical Operations (AI/ML, automation, data analytics, etc.) Collaboration & Communication Work proactively and collaboratively with client stakeholders, technology teams, and Sonata’s extended delivery team to drive alignment and delivery. Serve as the SME (Subject Matter Expert) liaison between Clinical Operations and technical implementation teams. Technology Enablement Provide business input and validation for configuration, integration, and deployment of clinical systems such as CTMS, EDC, eTMF, RTSM, and Safety systems. Ensure that implemented solutions meet both business and regulatory requirements. Participate in solution design reviews, testing (UAT), and change management initiatives. Project Delivery Support Support end-to-end implementation efforts including planning, execution, monitoring, and post-go-live support. Help define KPIs and success criteria for clinical operations initiatives and technology deployments. Key Skills & Experience: Domain Expertise: In-depth knowledge of Clinical Trials and Clinical Operations processes. Familiarity with regulatory standards and industry frameworks (ICH-GCP, 21 CFR Part 11, DIA, etc.). Technology Understanding: Strong functional knowledge of clinical systems (CTMS, EDC, eTMF, RTSM, Safety/Pharmacovigilance platforms). Awareness of integration points, data flows, and interoperability across clinical platforms. Business Analysis Skills: Proven experience in creating high-quality functional specifications , process flows , and traceability matrices . Excellent analytical and problem-solving skills; ability to think strategically and execute tactically. Communication & Collaboration: Strong interpersonal skills with the ability to work across business and technical teams. Proactive, self-driven, and able to manage multiple stakeholders and priorities effectively. Tools: Proficiency in tools such as Jira , Confluence , Visio , MS Office , and requirement management platforms. Preferred Qualifications: Experience working with global Pharma/Biotech clients. Exposure to Agile/Scrum and/or Waterfall project methodologies. Certification in Business Analysis (e.g., CBAP, PMI-PBA) or Clinical Research (e.g., ACRP, SOCRA) is a plus.