Principal Clinical Business Analyst

Due to our continued growth we are hiring a Principal Clinical Business Analyst (CBA) to join our global team. This is a remote role based in Hungary, Poland, Romania, Serbia or Slovakia.

Principal Clinical Business Analyst (CBA) serves as a leader in the planning, design, development, implementation, and adoption of a Business Operation Systems to support clinical study delivery. The Principal CBA has knowledge and expertise in complex and highly visible clinical or operational processes and ensures that the related system meets operational needs. The Principal CBA has expertise in the system and leverages data and metrics to evaluate system adoption by clinical teams.

Role Responsibilities:

• Ensures system adoption through training, communication, hands-on demonstrations and stakeholder engagement.
• Escalates concerns leadership when additional intervention is required.
• Leads or supports system implementation, including testing, training and supporting existing and new systems.
• Understand the needs and pain points of the Business Operation Systems.
• Uses this knowledge to provide advice, guidance and remove barriers.
• Coordinates and conducts stakeholder requirements discussions to understand system functional requirements and adoption barriers.
• Ensures an effective resolution of process and service risks that prevent user progress and effective delivery.
• Identifies experts and uses escalation routes to deliver quick solutions.
• Using current and future end-user business needs, develops and documents specifications for system selection, operations, and configuration.
• Collaborates with functional teams to update Business Operation Systems configurations, i.e. templates, reports, dashboards, and/or milestones. 
• Supports integrations within and across Business Operation Systems platforms, as well as with external systems when appropriate.
• Oversees new system version releases and configuration changes, including testing, and validation oversight or as needed User Acceptance Testing (UAT) execution.
• Develops System processes, procedures and best practices for both technical support teams and clinical teams.
• Participates in audit and regulatory inspection preparation activities and assist in the development and delivery of CAPA to time and quality, when applicable.
• Participates in inspection/audit preparation activities and assist in the development and execution of CAPA plans, when applicable.
• Continuously monitor Business Operation Systems for ways to increase efficiency in business process and end-user experience.
• Provides system leadership with strategic insights and recommendations, connecting the dots between systems, processes, roles and responsibilities, and structure to ensure optimal operational efficiency.
• Collaborates with system leadership to identify areas of enhancements and developing plans for optimal operational efficiency across multiple complex systems.
• Supports Leadership with the creation and management of the system based on the functional system requests or update requests.
• Understands and analyses the business context, the users, and the roadmap for the assigned system.
• Actively looks to promote creative and innovative ideas to drive performance and bring new solutions to the Business Operation Systems users.
• Shares lessons learned and best practice recommendations with the Business Operation Systems team.
• Supports with review and/or development of training materials related to the Business Operation Systems. 

Education and Experience 

• Bachelor’s degree (or its international equivalent) + 8 years of experience with relevant or related system and processes.
• Experience working in a matrixed environment.
• Experience and expertise in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations.
• Knowledge in transforming business process requirements into Functional Requirements.
• Experience leading teams directly or indirectly to achieve operational outcomes.
• Ability to work collaboratively, motivate and empower others to carry out individual, team and organizational objectives.
• Communicate effectively in the English Language.
• Prior experience in a Clinical Operations role, handling systems.
• Possess the ability to effectively communicate business needs to IT technology partners.
• Experience with change management and user adoption strategies.

Knowledge, Skills, and Competencies:

• Ability to resolve issues independently with good judgement to escalate appropriately.
• Excellent interpersonal, verbal and written communication skills
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Ability to identify, diagnose and resolve technology problems.
• Ability to lead system implementations and drive adoption.
• Strong strategic thinking, change management and stakeholder engagement skills.
• Anticipate and balancing the needs of multiple stakeholders.