Principal Clinical Business Analyst

3 days, 20 hours ago
Full-time
Lead
Data Science and Analytics
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

  • Ensure system adoption through training, communication, hands-on demonstrations, and stakeholder engagement.
  • Lead or support system implementation, including testing, training, and support for new and existing systems.
  • Coordinate stakeholder requirements discussions to understand functional requirements and adoption barriers.
  • Identify and remove operational barriers by providing guidance on business operation system needs and pain points.
  • Develop and document specifications for system selection, operations, and configuration based on end-user needs.
  • Collaborate with functional teams to update system configurations such as templates, reports, dashboards, and milestones.
  • Support integrations within and across business operation systems platforms and with external systems when appropriate.
  • Oversee system version releases and configuration changes, including testing, validation oversight, and UAT execution.
  • 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 experience with relevant systems and processes.
  • Experience working in a matrixed environment.
  • Experience and expertise in 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.
  • Prior experience in a Clinical Operations role handling systems.
  • Experience with change management and user adoption strategies.
  • Ability to communicate effectively in English.
  • Strong analytical, problem-solving, organizational, interpersonal, and stakeholder engagement skills.

Interested in this position?

Apply directly on the company website

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