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Business Consultant - Clinical Operations & Technology

Faites partie des premiers candidats.
E-Solutions
Grande-Bretagne
GBP 40 000 - 60 000
Faites partie des premiers candidats.
Aujourd’hui
Description du poste
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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* Le salaire de référence se base sur les salaires cibles des leaders du marché dans leurs secteurs correspondants. Il vise à servir de guide pour aider les membres Premium à évaluer les postes vacants et contribuer aux négociations salariales. Le salaire de référence n’est pas fourni directement par l’entreprise et peut pourrait être beaucoup plus élevé ou plus bas.

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