Business Consultant – Clinical Operations

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.