About the Job
The Sr. Manager, Clinical Trial Systems is responsible for driving the development, implementation and oversight strategy for the systems and infrastructure that supports the execution of clinical trials at FMI by the Clinical Operations and Data Management organization. This role is responsible for the design, management and oversight of all department-related systems, including the evaluation and elicitation of requirements for new systems. The incumbent is the primary interface and point of contact with FMI technology teams and systems and process owners. They ensure a complete systems roadmap is delivered, maintained and executed, requirements are captured, stories are generated and confirmed, and work is prioritized in development sprints. This role partners with Quality Systems to ensure validation is complete and maintained for regulated systems. This position ensures Business System Ownership is provided for cross-functional systems and tools, and provides actionable reports and metrics related to clinical trial execution (through dashboards) to all relevant stakeholders. This role develops and maintains a Business Process Management Methodology to support cross-functional process and system improvements in Clinical Operations and Data Management.
• Drive the development, implementation and oversight strategy for department systems and infrastructure that supports the execution of clinical trials at FMI.
• Accountable for the coordination and prioritization of the systems roadmap on behalf of Clinical Operations and Data Management in collaboration with FMI technology and business partners.
• Develop and refine department strategy for system and information management in order to ensure current systems and reporting platforms are meeting needs of business objectives.
• Ensures that the requirements, design, timelines and resources of system implementations are available and defined to be capable of meeting clear business objectives.
• Partners effectively with Systems Quality Assurance team to ensure systems are validated to meet international regulations and guidance.
• Ensures management, continued development and implementation of current FMI Clinical Operations and Data Management systems, including data reporting system, partner-facing portal, Clinical Trial Management System (CTMS), and other electronic tools that support process execution.
• Ensures information is available to support trending and reporting requirements; works with business owners to develop dashboards that provide actionable data.
• Ensures that an effective helpdesk is operational for Clinical Operations and Data Management systems in support of the global user communities.
• Liaises with Clinical Operations and Data Management leadership to identify potential synergies and/or opportunities for process improvements and system solutions.
• Accountable for the support of cross-functional business and technology process improvements, including User Acceptance Testing oversight and coordination.
• Ensures efficient and effective leadership of Clinical Trial Systems is represented and working effectively both globally and locally.
• Contribute to the development and execution of department goals and initiatives.
• Participate in or lead departmental or cross-functional projects and initiatives as assigned.
• Assists and/or contributes to the development and/or revision of department or systems Standard Operating Procedures (SOPs), guidelines and tools.
• Participates on projects as a sponsor or lead.
• Other duties pertinent to Strategic Operations as occasionally assigned.
• Bachelor’s degree or equivalent in scientific or computer engineering field or equivalent combination of education, training and experience
• 6+ years of systems or IT or systems integration experience in a professional life sciences environment
• Masters or Advanced Degree in a business or scientific discipline
• 8-10 years of experience in pharmaceutical, medical device or biotech industry; understanding of CSV and Good Clinical Practice regulations and guidelines
• Experience in business process management or training management or Lean Sigma
• Understanding of international CSV regulatory requirements, guidelines, and policies
• Demonstrated ability with project management, organizational and planning
• Demonstrated ability to effectively organize and execute tasks
• Demonstrated ability to work well under pressure while maintaining a professional demeanor
• Knowledge of Computer System Validation (CSV) regulations and internal policies and SOPs
• Knowledge of clinical trial regulatory requirements and how these requirements relate to the drug development process
• Highly effective teamwork and collaboration skills
• Understanding of HIPAA and importance of patient safety and data privacy regulations and guidelines• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration
Internal applicants, please use your FMI email address.