Principal Clinical Business Analyst

3 weeks, 3 days ago
Full-time
Lead
Business Intelligence
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012

Description

  • Lead the planning, design, development, implementation, and adoption of business operation systems that support clinical study delivery.
  • Ensure system adoption through training, communication, hands-on demonstrations, and stakeholder engagement.
  • Lead or support system implementations, including testing, training, and support for both existing and new systems.
  • Coordinate stakeholder requirements discussions to define functional requirements and identify adoption barriers.
  • Document specifications for system selection, operations, and configuration based on current and future end-user needs.
  • Collaborate with functional teams to update system configurations, including templates, reports, dashboards, and milestones.
  • Support integrations within and across business operation systems platforms and with external systems when appropriate.
  • Oversee new system releases and configuration changes, including testing, validation oversight, and UAT execution as needed.
  • Develop system processes, procedures, and best practices for technical support teams and clinical teams.
  • Participate in audit and regulatory inspection preparation and support CAPA development and execution when applicable.

Requirements

  • Bachelor’s degree or international equivalent plus 8 years of relevant system and process experience.
  • Experience working in a matrixed environment.
  • Experience with clinical trial systems such as CTMS, EDC, eTMF, and RTMS.
  • Detailed understanding of requirements gathering, documentation, configuration, and integrations.
  • Knowledge of transforming business process requirements into functional requirements.
  • Experience leading teams directly or indirectly to achieve operational outcomes.
  • Experience in a Clinical Operations role handling systems.
  • Experience with change management and user adoption strategies.
  • Strong English communication skills.
  • Ability to communicate business needs effectively to IT technology partners.

Interested in this position?

Apply directly on the company website

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