About the Job

The Sr Mgr, Strategic Operations is responsible for the overall development, implementation, user training, and continuous improvement for the processes, systems and infrastructure that supports the execution of clinical trials at FMI by the Clinical & Scientific Operations organization. This position ensures that FMI maintains audit readiness for our partners and for regulatory authorities and implements necessary improvements and updates to processes and procedures. This role is responsible for the evaluation of existing process and in creating efficiencies and improvements through process improvement and the addition of technology-based solutions where possible. The incumbent is responsible for ensuring a complete process and systems roadmap is developed and delivered in accordance with existing processes, taking ownership for the gathering of customer requirements, establishing training plans, supporting the transition of new tools and processes to functional owners, and establishing continuous improvement plan. This role partners with internal stakeholders within Clinical Operations and Data Management, Regulatory Affairs, Dx Development and with cross-functional stakeholders in FMI, including the Quality team where appropriate to ensure that processes are accurate and continuously improved relative to the needs of the organization and our regulated activities. This role develops and maintains a Business Process Management Methodology to support cross-functional process improvements in Clinical & Scientific Operations. 

Key Responsibilities

• Function as a global process owner for Clinical & Scientific Operations processes and procedures, including revising department or systems Standard Operating Procedures (SOPs), guidelines and tools.
• Support or lead CAPA development for functional processes through assessment and ongoing tracking of deviations and non-conformances as they relate to and impact profiling studies, diagnostic protocols, performance studies and CDx validation studies.
• Contribute to and execute on a continuous improvement strategy for all department processes and procedures.
• Contribute to the development and execution of department goals and initiatives.
• Participate in or lead departmental or cross-functional projects and initiatives as assigned.
• Support change management efforts by establishing key events, timelines and ensuring communications are established for both internal and external stakeholders, as applicable.
• Facilitate and oversee department training activities and manage training and personnel records. 
• Accountable for the support of cross-functional business and technology process improvements, including User Acceptance Testing oversight and coordination and user training.
• Ensure that the requirements, design, timelines and resources of new system implementations are available and defined to be capable of meeting clear business objectives.
• With an emphasis on external customer and internal stakeholder needs, ensures sound management, continued development and implementation of current FMI Clinical and Scientific Operations systems and processes, including those used for study management, sample management, clinical validation studies and CDx submissions, and data reporting.
• Other duties pertinent to Strategic Operations as occasionally assigned.

Qualifications

Basic Qualifications

• Bachelor’s degree or equivalent in science field or equivalent combination of education, training and experience
• 8+ years of experience working in a professional life sciences environment or field involving the management of clinical trials or diagnostic development

Preferred Qualifications

• Master’s degree in a business or scientific discipline
• 7+ years of experience in pharmaceutical, medical device or biotech industry; understanding of Good Clinical Practice and Device regulations and guidelines
• Experience in business process management or training management or Lean Sigma
• 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 clinical trial regulatory requirements and how these requirements relate to the drug and device 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