Principal Clinical Business Analyst
RemotePoland or Serbia
Job Summary
Lead planning, design, and implementation of Business Operation Systems to support clinical study delivery, ensuring system adoption through training, stakeholder engagement, and hands-on demonstrations. Coordinate requirements discussions to define functional specifications, manage configuration updates for templates and dashboards, and oversee system version releases including User Acceptance Testing. Resolve process and service risks by identifying experts and escalating concerns to leadership, while developing system processes, procedures, and best practices for technical and clinical teams. Monitor systems for efficiency improvements and provide strategic insights to optimize operational performance across multiple complex platforms. Prepare for audit and regulatory inspections by developing and executing CAPA plans.
Required Qualifications
- Bachelor's degree (or its international equivalent)
- 8 years of experience with relevant or related system and processes
- Experience working in a matrixed environment
- Experience and expertise in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations
- Knowledge in transforming business process requirements into Functional Requirements
- Experience leading teams directly or indirectly to achieve operational outcomes
- Ability to work collaboratively, motivate and empower others to carry out individual, team and organizational objectives
- Communicate effectively in the English Language
- Prior experience in a Clinical Operations role, handling systems
- Possess the ability to effectively communicate business needs to IT technology partners
- Experience with change management and user adoption strategies
- Ability to resolve issues independently with good judgement to escalate appropriately
- Excellent interpersonal, verbal and written communication skills
- Excellent organizational skills and attention to detail
- Strong analytical and problem-solving skills
- Ability to identify, diagnose and resolve technology problems
- Ability to lead system implementations and drive adoption
- Strong strategic thinking, change management and stakeholder engagement skills
- Anticipate and balancing the needs of multiple stakeholders
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