Principal Clinical Business Analyst

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

📋 Description

• Facilitates system adoption through training, effective communication, hands-on demonstrations, and engagement with stakeholders.

• Raises issues with leadership when further intervention is necessary.

• Guides or assists in system implementation, which includes testing, training, and support for both existing and new systems.

• Recognizes the needs and challenges within 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 barriers to adoption.

• Ensures that process and service risks that hinder user progress and effective delivery are resolved efficiently.

• Identifies experts and employs escalation channels to quickly provide solutions.

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

• Works in collaboration with functional teams to refresh configurations of Business Operation Systems, including templates, reports, dashboards, and/or milestones.

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

• Manages new system version releases and configuration modifications, including testing and validation oversight, or executes User Acceptance Testing (UAT) as required.

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

• Engages in audit and regulatory inspection preparation activities and contributes to the development and timely delivery of CAPA as necessary.

• Involved in inspection/audit preparation and aids in creating and executing CAPA plans, when applicable.

• Continuously assesses Business Operation Systems for opportunities to enhance efficiency in business processes and user experience.

• Provides strategic insights and recommendations to system leadership, bridging connections between systems, processes, roles, responsibilities, and structures to ensure optimal operational efficiency.

• Collaborates with system leadership to pinpoint enhancement opportunities and devise plans for maximizing operational efficiency across multiple complex systems.

• Aids leadership in the creation and management of the system based on functional system requests or updates.

• Comprehends and analyzes the business context, user demographics, and the roadmap for the assigned system.

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

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

• Assists in reviewing and/or developing training materials associated with the Business Operation Systems.

⛳️ Requirements

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

• Proven experience in a matrixed environment.

• In-depth experience and knowledge of clinical trial systems (e.g., CTMS, EDC, eTMF, and RTMS), particularly in requirements gathering, documentation, configuration, and integrations.

• Proficient in translating business process requirements into functional specifications.

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

• Capability to work collaboratively, inspire, and empower others to meet individual, team, and organizational objectives.

• Proficient communication skills in the English language.

• Previous experience in a Clinical Operations role managing systems.

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

• Familiarity with change management and user adoption strategies.

🏝️ Benefits

• Health insurance

• Paid time off

• Flexible work arrangements

• Professional development