About the Job

The Manager, Strategic Operations is responsible for the development, implementation, user training, and continuous improvement of the processes, systems and infrastructure that supports the execution of profiling studies and CDx validation studies at FMI by the Clinical & Scientific Operations (CSO) organization. This role leverages project and process management best practices, tools and frameworks to support the planning and delivery of key programs/projects that drive continuous improvement and performance of business operations and the achievement of organizational Objectives and Key Results (OKRs). This role is responsible for the evaluation and stewardship of existing regulated business processes and systems to ensure audit readiness for our partners and for regulatory authorities, implementing necessary improvements and updates to processes and procedures as needed. 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 Assurance 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 supports the development and maintenance of a Business Process Management Methodology to support cross-functional process improvements in Clinical & Scientific Operations. 

Key Responsibilities

• Continuous Improvement & Change Management:
  • Support change management efforts by developing plans that define key events/timelines, and by ensuring communications and enablement activities are established for both internal and external stakeholders
  • Lead and support cross-functional business and technology process improvement activities, including User Acceptance Testing oversight and development and coordination of end user training
  • Ensure that the requirements, design, timelines and resources of new process and/or system implementations are available and defined to be capable of meeting clear business objectives
  • Lead and support projects and activities specific to CSO Objectives and Key Results (OKRs), driving and managing the completion of supporting tasks, collaboration activities and key deliverables
  • Leverage core communication and change management methodologies and tools to support delivery of internal and external communication and change management efforts
  • Contribute to the development and execution of departmental goals and initiatives as assigned
• Business Process & Training Management:
  • Lead and support the management and development/continuous improvement of CSO regulated processes and trainings used for study management, sample management, clinical validation studies and CDx submissions, and data reporting
  • Lead and support the development, implementation and oversight of a Business Process Management Model framework that establishes business process ownership and best practices/tools to ensures processes are fit-for-purpose, scalable and compliant
  • Serve as a centralized resource and steward of work procedures, including revising department or systems Standard Operating Procedures (SOPs), Work Instructions (WIs), guidelines and templates/tools
  • Define department training curricula and training strategy
  • 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
• Project Management & Communications:
  • Lead the planning, management and delivery of CSO/cross-functional initiatives and projects and associated deliverables (incl. business case development), to improve the performance, efficiency and compliance of internal operations, and the execution of profiling studies and CDx validation studies
  • Manage projects that support continuous improvement within the organization, working with all levels of the organization, and cross-functionally as needed
  • Plan and facilitate collaboration forums (brainstorming, workshops, etc.), managing the overall execution and driving the completion of associated action items, key deliverables and target outcomes
  • Develop and ensure the utilization of program/project charters and plans, including scope, timeline, risks, and resources and track key project milestones and metrics
  • Drive cross-functional team ownership and commitment to key program/project plans and associated deliverables
  • Manage and support internal/external communication strategies and activities, collaborating with key stakeholders to plan, develop key content/tools, set timelines/milestones and manage the execution of associated activities
  • Establish departmental standards and best practices related to internal program/project management, creating and optimizing frameworks, tools and templates that ensure quality, efficiency and effectiveness in project delivery
• Perform other duties pertinent to Strategic Operations as assigned

Qualifications:

Basic Qualifications:

• Bachelor’s degree or equivalent in science field or equivalent combination of education, training and experience
• 5+ 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
• 5+ years of experience in pharmaceutical, medical device or biotech industry; understanding of Good Clinical Practice and Device regulations and guidelines
• 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
• Experience in business process management or training management or Lean Sigma
• 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, GDPR and importance of patient safety and international data privacy regulations and guidelines
• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration

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