Business Consultant - Clinical Operations & Technology

E-Solutions; United Kingdom; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading clinical solutions provider is seeking a Business Analyst to optimize clinical processes and engage with stakeholders. The role requires in-depth knowledge of Clinical Trials, regulatory standards, and strong analytical skills. Ideal candidates will collaborate across teams and support project delivery effectively. Flexibility and proficiency with tools like Jira and Confluence are essential. Join us to lead innovations in Clinical Operations.

Qualifications

• In-depth knowledge of Clinical Trials and Clinical Operations processes.
• Familiarity with regulatory standards and industry frameworks.
• Excellent analytical and problem-solving skills.

Responsibilities

• Engage with stakeholders to document business needs.
• Analyze existing clinical processes for optimization.
• Support end-to-end implementation efforts.

Skills

Domain expertise in Clinical Trials

Strong functional knowledge of clinical systems

Proven experience in creating functional specifications

Strong interpersonal skills

Proficiency in Jira

Education

Certification in Business Analysis or Clinical Research

Tools

Jira

Confluence

Visio

MS Office

Job description

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.