Principal Clinical Business Analyst

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

📋 Description

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

• Raises concerns to leadership when additional intervention is necessary.

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

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

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

• Organizes and leads discussions with stakeholders to gather requirements and identify barriers to system functionality and adoption.

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

• Identifies subject matter experts and employs escalation pathways to deliver prompt solutions.

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

• Collaborates with functional teams to revise Business Operation Systems configurations, such as templates, reports, dashboards, and milestones.

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

• Manages new system version releases and configuration modifications, including testing and validation oversight, as well as User Acceptance Testing (UAT) execution when needed.

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

• Takes part in audit and regulatory inspection preparation activities and aids in the development and delivery of CAPA within established timelines and quality standards, as applicable.

• Engages in inspection/audit preparation and assists in the creation and execution of CAPA plans, when relevant.

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

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

• Works with system leadership to pinpoint areas for enhancement and develop strategies for optimal operational efficiency across multiple complex systems.

• Assists leadership in the creation and management of the system based on functional system requests or update needs.

• Understands and evaluates the business context, user needs, and roadmap for the assigned system.

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

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

• Assists in reviewing and/or developing training materials related to the Business Operation Systems.

⛳️ Requirements

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

• Experience in a matrixed environment.

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

• Knowledgeable in converting business process requirements into Functional Requirements.

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

• Ability to collaborate effectively, inspire, and empower others to fulfill individual, team, and organizational objectives.

• Strong communication skills in the English language.

• Previous experience in a Clinical Operations role, dealing with systems.

• Capable of effectively conveying business needs to IT technology partners.

• Familiarity with change management and user adoption strategies.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off