Principal Clinical Business Analyst

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

📋 Description

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

• Raises issues to leadership when further intervention is necessary.

• Takes the lead or provides support in system implementation, which includes testing, training, and assisting with both existing and new systems.

• Recognizes the needs and challenges associated with Business Operation Systems.

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

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

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

• Identifies subject matter experts and utilizes escalation channels to provide swift solutions.

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

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

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

• Manages new system version releases and configuration changes, which entails testing and, when necessary, overseeing User Acceptance Testing (UAT).

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

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

• Takes part in inspection/audit preparation activities and assists in the formulation and execution of CAPA plans, when applicable.

• Continuously assesses Business Operation Systems to identify opportunities for improving efficiency in business processes and enhancing end-user experience.

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

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

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

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

• Proactively seeks to promote innovative ideas that enhance performance and deliver new solutions to the users of Business Operation Systems.

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

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

⛳️ Requirements

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

• Experience in a matrixed 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.

• Proven experience in leading teams, either directly or indirectly, to achieve operational results.

• Capability to work collaboratively, inspire, and empower others to accomplish individual, team, and organizational goals.

• Effective communication skills in English.

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

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

• Familiarity with change management and strategies for user adoption.

🏝️ Benefits

• Private medical insurance

• MultiSport Card

• Life insurance

• Pension plan

• Home working allowance

• Vacation time