Principal Clinical Business Analyst

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

📋 Description

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

• Elevates issues to leadership when additional intervention is necessary.

• Leads or assists in system implementation, encompassing testing, training, and support for both existing and new systems.

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

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

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

• Guarantees a timely resolution of process and service risks that hinder user progress and efficient delivery.

• Recognizes experts and employs escalation pathways to provide rapid 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 modify Business Operation Systems configurations, such as templates, reports, dashboards, and/or milestones.

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

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

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

• Engages in audit and regulatory inspection preparation activities and aids in the creation and delivery of CAPA to meet timelines and quality standards, when applicable.

• Participates in preparation for inspections/audits and assists in the formulation and execution of CAPA plans, when applicable.

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

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

• Collaborates with system leadership to identify enhancement areas and formulate 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, user requirements, and roadmap for the assigned system.

• Actively seeks to promote creative and innovative 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.

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

⛳️ Requirements

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

• Proven experience working in a matrixed environment.

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

• Proficient in translating business process requirements into Functional Requirements.

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

• Ability to foster collaboration, inspire, and empower others to fulfill individual, team, and organizational objectives.

• Effective communication skills in the English language.

• Previous experience in a Clinical Operations role, managing systems.

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

• Familiarity with change management and user adoption strategies.

🏝️ Benefits

• Comprehensive health benefits package.

• Opportunities for professional development and advancement.

• Flexible working arrangements.

• Collaborative and inclusive work environment.