Strategic Operations Manager
Company: Disability Solutions
Location: Boston
Posted on: May 8, 2024
Job Description:
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
#LI-Hybrid
Keywords: Disability Solutions, Boston , Strategic Operations Manager, Executive , Boston, Massachusetts
Didn't find what you're looking for? Search again!
Loading more jobs...