Principal Clinical Business Analyst

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Facilitates system adoption by providing training, effective communication, practical demonstrations, and engaging stakeholders.

• Raises issues to leadership when further intervention is necessary.

• Takes charge of or assists with system implementation, which includes testing, training, and supporting both existing and new systems.

• Understands the needs and challenges of the Business Operation Systems.

• Utilizes this understanding to offer advice, guidance, and eliminate obstacles.

• Organizes and leads discussions with stakeholders to grasp system functional requirements and adoption challenges.

• Ensures timely resolution of process and service risks that hinder user progress and effective delivery.

• Identifies experts and leverages escalation procedures to provide swift solutions.

• Based on current and anticipated end-user business needs, formulates and documents specifications for system selection, operations, and configuration.

• Works collaboratively with functional teams to revise Business Operation Systems configurations, including templates, reports, dashboards, and/or milestones.

• Assists with integrations within and across Business Operation Systems platforms, as well as with external systems when suitable.

• Manages new system version releases and configuration changes, including testing and oversight of validation or necessary User Acceptance Testing (UAT) execution.

• Develops processes, procedures, and best practices for both technical support teams and clinical teams.

• Engages in audit and regulatory inspection preparation activities and supports the development and timely delivery of CAPA when applicable.

• Participates in inspection/audit preparation efforts and aids in the formulation and execution of CAPA plans, when necessary.

• Continuously evaluates Business Operation Systems for opportunities to enhance business processes and improve end-user experience.

• Provides system leadership with strategic insights and recommendations, linking systems, processes, roles, responsibilities, and structures to ensure maximum operational efficiency.

• Collaborates with system leadership to pinpoint areas for enhancement and formulates plans for optimal operational efficiency across multiple complex systems.

• Assists leadership in creating and managing the system based on functional system requests or updates.

• Analyzes the business context, users, and roadmap for the assigned system.

• Proactively seeks to promote creative and innovative ideas to enhance performance and introduce new solutions to Business Operation Systems users.

• Shares lessons learned and best practice recommendations with the Business Operation Systems team.

• Assists in the review and/or creation of training materials related to the Business Operation Systems.

⛳️ Requirements

• Bachelor’s degree (or its international equivalent) with 8 years of relevant or related experience in systems and processes.

• Background in a matrixed work environment.

• Proficiency in clinical trial systems (e.g., CTMS, EDC, eTMF, and RTMS) with a comprehensive understanding of requirements gathering, documentation, configuration, and integrations.

• Knowledge in converting business process requirements into Functional Requirements.

• Experience in leading teams, either directly or indirectly, to achieve operational goals.

• Capability to collaborate effectively, inspire, and empower others to meet individual, team, and organizational objectives.

• Proficient in communicating effectively in English.

• Previous experience in a Clinical Operations role involving systems management.

• Ability to convey business needs to IT technology partners effectively.

• Familiarity with change management and user adoption strategies.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options