Senior Continuous Improvement Manager

POSITION TITLE: Senior Continuous Improvement Manager

DEPARTMENT: Transformation Office

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role:

The Senior Continuous Improvement Manager is a new role supporting the Transformation Office at Ora. The Senior Continuous Improvement Manager will work in a hybrid role, managing Continuous Improvement initiatives and providing Project Director oversight for assigned clinical trials at Ora. These responsibilities include promoting and facilitating continuous improvement initiatives, including systems and workflow optimization initiatives, across the organization. The role will support and lead projects to drive efficiency, effectiveness, technology/systems optimizations, and excellence in various processes, operations, and functions within the organization in alignment with the overall corporate and transformation strategy. In addition, the individual may serve as Project Director on select clinical trials, based on business needs. The role will report to the Director, Continuous Improvement.

What You’ll Do:

Continuous Improvement (Approximately 75% of Focus)

• Collaborate with cross-functional teams to develop and support the implementation of methodologies and tools that promote a culture of continuous improvement, fostering increased business process maturity through data-driven insights and performance metrics.
• Lead projects, under the direction of the Director, Continuous Improvement, which drive the assessment, analysis, and enhancement of existing business processes to ensure continuous improvement, emphasizing the evolution of process maturity and alignment with organizational goals.
• Lead process improvement projects, from idea generation and business justification through implementation and confirmation of results, aimed at optimizing processes, reducing inefficiencies, and fostering innovation to enhance overall operational excellence.
• Support in the maintenance of Process Maps and Responsibility Matrices for all of the organization’s business processes, including periodic reviews and updates as well as critical reviews for process improvement opportunities.
• Identify potential improvement projects by evaluating the organization for inefficiency and/or complexity.
• Provide mentorship and guidance for other Ora employees on Continuous Improvement principals and methodologies.
• Aid in the definition and maintenance of project management policies, processes, and templates applicable to Continuous Improvement work.
• Communicate project status, risks, and issues to stakeholders in a clear and timely manner.
• Support in the planning of resource allocation and capacity planning to maximize project delivery efficiency.
• Identify risks and develop risk mitigation strategies.
• Ensure compliance with regulatory requirements and industry standards.
• Support the implementation of lessons learned and feedback mechanisms to drive improvements.

Project Oversight (Approximately 25% of Focus)

• Manage the scope of work, objectives, quality of deliverables, and other project and study management activities in an oversight capacity for assigned clinical trials.
• Direct and lead project activities for team members on assigned studies related to their project-oriented tasks to ensure that project milestones are met. 
• Serve as primary project management delivery contact with clients for assigned studies to ensure appropriate communication channels are maintained and reporting schedules are adhered to. 
• Ensure the development of project plans for all phases of the project lifecycle, including quality and risk management, ensuring that issue escalation and resolution is clear. 

General

• Adhere to all aspects of Ora’s quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.
• Travel of up to 5% may be required (mainly domestic, overnight). 

What We Look For: 

• Experience Needed for the Role:
  • Bachelor's degree or higher.
  • 5+ years of project management experience leading process-driven teams and initiatives with the ability to foster an inspiring, collaborative environment.
  • 8+ years of experience in clinical trials.
  • Understanding of Continuous Improvement methodologies and confirmed project management experience in a fast-paced clinical trial management environment.

• Additional Skills and Attributes:
  • Prior Ophthalmology clinical trial experience and prior CRO experience is strongly preferred.
  • Prior experience across a broad range of clinical trial management-related processes in an internal or consultant role is preferred.
  • Curious, continually challenging the status quo, and able to explore what should change to best meet evolving business needs in an accelerated environment.
  • Strong executive presence with communication and facilitation skills that foster collaboration, unify stakeholders, and advocate for positive change.
  • Ability to “see the big picture” and bring structure and clarity to ambiguous situations.
  • Lean-Six Sigma certification is a plusLeadership experience in a matrix environment.
  • Experience in strategic planning, change management, and process improvement.
  • Proficiency in defining and tracking KPIs and metrics.
  • Understanding of risk management and the ability to develop risk mitigation strategies.

• Competencies and Personal Traits:
  • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
    • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

What We Offer:

• Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.  
• Financial: Competitive salaries along with a 401K plan through Fidelity with company match. 
• Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. 
• Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure. 
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. 
• Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family. 
• Career Development Opportunities: Continued opportunities to grow and develop your career journey.  
• Global Team: Opportunities to work with colleagues across the globe. 
• Impact: A chance to research new ophthalmic therapies that will impact patients across the globe. 

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. 

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member. 

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.