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 supporting clinical study delivery.
  • Drive system adoption through training, communication, hands-on demonstrations, and stakeholder engagement.
  • Lead or support system implementation activities, including testing, training, and support for new and existing systems.
  • Coordinate stakeholder requirements discussions to gather functional requirements and identify adoption barriers.
  • Document specifications for system selection, operations, and configuration based on end-user business needs.
  • Collaborate with functional teams to update system configurations such as templates, reports, dashboards, and milestones.
  • Support integrations within and across business operation system platforms and with external systems when needed.
  • Oversee system version 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 experience with related systems and processes.
  • 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.
  • Prior experience in a Clinical Operations role handling systems.
  • Experience with change management and user adoption strategies.
  • Strong English communication skills, both verbal and written.
  • Ability to communicate business needs effectively to IT technology partners.
  • Ability to resolve issues independently and escalate appropriately using good judgment.
  • Strong interpersonal, organizational, analytical, and problem-solving skills.
  • Ability to identify, diagnose, and resolve technology problems.
  • Strong strategic thinking, stakeholder engagement, and change management skills.
  • Ability to balance the needs of multiple stakeholders.

Benefits

  • Remote role based in Hungary, Poland, Romania, Serbia, or Slovakia.
  • Opportunity to join a global team at a growing organization.
  • Work on clinical research systems supporting trials from early development through approval.
  • Exposure to oncology and rare disease programs.

Interested in this position?

Apply directly on the company website

Apply Now

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