lavori da Pharmacovigilance in località Regno Unito

Business Consultant - Clinical Operations & Technology

Business Consultant - Clinical Operations & Technology

E-Solutions

Regno Unito

GBP 40.000 - 60.000

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Business Consultant - Clinical Operations & Technology

E-Solutions

Regno Unito

GBP 40.000 - 60.000

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Descrizione del lavoro

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.

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* Il benchmark retributivo si basa sugli obiettivi retributivi dei leader del mercato nei rispettivi settori. È pensato per orientare gli utenti Premium nella valutazione delle posizioni aperte e aiutarli a negoziare la propria retribuzione. Tale benchmark non è fornito direttamente dall'azienda, quindi la retribuzione effettiva potrà risultare anche notevolmente superiore o inferiore.