Director, Certification and Site Operations - OptymEdge

Job Title: Director, Certification and Site Operations

Location: US - Remote

Primary Purpose

As OptymEdge continues to scale its certification model and expand its global site network, the Director, Certification and Site Operations will lead the strategy, structure, and performance of the Certification and Site Operations function. This role is responsible for building and managing a global ecosystem of certified sites, ensuring examiners and rooms maintain active certification status and are continuously ready to support new and ongoing clinical trials.

This role will define and standardize the certification model across studies, enabling efficient site activation, reducing start-up timelines, and ensuring consistency in endpoint delivery. The Director will work in close partnership with Project Delivery, Technology, and Clinical leadership to align certification operations with study execution and digital platform capabilities, ensuring certification and site readiness function as a scalable, reliable foundation for all clinical trial delivery.

• Define and lead the strategic vision for Certification & Site Operations, ensuring a scalable, consistent, and high-quality global certification and site readiness model.
• Provide executive leadership to certifiers, clinical liaisons, and operational support teams, fostering a culture of accountability, consistency, and high performance.
• Translate organizational strategy into operational plans for certification and site readiness, aligning with Project Delivery, Technology, and Clinical functions.
• Own and evolve the global certification model, including initial certification, bridge, transfer, and recertification pathways, ensuring standardization and efficiency across all studies.
• Lead the development and management of the OptymEdge certified site network, ensuring examiners and rooms maintain active certification status and are continuously trial-ready.
• Establish and oversee processes to manage certification lifecycle, including tracking, expirations, and recertification, ensuring uninterrupted site readiness across the portfolio.
• Drive strategies to enable reuse of certified examiners and rooms across studies, reducing start-up timelines and improving overall delivery efficiency.
• Ensure clinical quality and consistency of endpoint execution across certified sites, supporting audit readiness and minimizing variability.
• Establish and monitor KPIs across certification and site operations, including certification cycle times, recertification compliance, site readiness, and network utilization.
• Serve as the business owner for certification-related platform capabilities, including Acuvera Certify, aligning operational needs with product development and driving adoption.
• Partner closely with Project Delivery leadership to support study execution through a consistent and reliable certification framework, maintaining clear separation of responsibilities.
• Collaborate with Technology, Clinical, and Commercial teams to align certification operations with product strategy, endpoint requirements, and client expectations.
• Drive a culture of continuous improvement by leveraging data, performance metrics, and operational insights to enhance efficiency, scalability, and site experience.
• Lead workforce planning and capacity management for certification operations, ensuring appropriate global coverage and readiness to support study demand.
• Serve as a key member of the OptymEdge Leadership Team, contributing to enterprise strategy and decision-making.

Required Attributes

Vision and Strategy

• Sets objectives and key results for the Certification & Site Operations function in alignment with corporate strategy.
• Communicates and implements strategy at the operational level across certification delivery and site readiness.

Team Building

• Leads and builds effective teams across the certification function, including certifiers and clinical liaisons.
• Fosters collaborative relationships across Project Delivery, Technology, and Clinical teams to ensure an integrated approach to certification and site readiness.
• Sets and holds Direct Reports accountable for achieving their objectives.
• Mentors the next generation of leaders.
• Leads change consistent with company objectives.

Problem Solving

• Demonstrated strong problem solving and analytical skills, combined with business judgment.

Oversight

• Oversight of the Certification & Site Operations function with responsibility for consistent, high-quality certification delivery and site readiness across the global portfolio.

Metrics

• Collects, analyzes and provides metrics to ensure certification performance, site readiness, and network utilization meet or exceed operational expectations.

Culture

• Setting the cultural tone for the Certification & Site Operations function in alignment with Emmes values and providing inspirational leadership through example rather than decree.
• Exemplifies Emmes values in all actions and behavior.

Credibility and Integrity

• Developing executive presence and the ability to establish credibility with employees, certifiers, clinical liaisons, and business partners, with the ability to build consensus and achieve goals through influence versus direct line authority.
• Impeccable integrity as a leader and quickly seen as a role-model for leadership.

Continuous Improvement/Change Management

• Promptly takes the required corrective action when necessary.
• Continually assesses the operational effectiveness of certification models and site readiness processes, reevaluates approaches, and introduces innovations to improve efficiency and scalability.
• Brings new ideas and innovative solutions where practical to drive efficiency, enhanced quality and differentiating value to the client.
• Passion for improving human health.

Communication

• Communicates effectively across all levels of the organization, including clinical teams, operational leadership, and technology partners. Embraces cognitive diversity and listens actively to align teams and stakeholders. Provides clear, strategic updates to leadership and operational teams. Stays informed and communicates to others in a supportive manner regarding corporate activities.

Supervisor Responsibilities:

• Direct oversight of certifiers, clinical liaisons, and operational support roles within the Certification & Site Operations function.
• Responsible for leadership development and succession planning within the function

• Bachelor's degree in a scientific or clinical discipline (advanced degree preferred) or minimum 12-15 years' experience in ophthalmology, clinical research, or visual function assessments, with significant experience in certification, clinical operations, or site management.
• Proven experience managing or working with global clinical trial site networks.

• Strong understanding of visual function endpoints and certification requirements in clinical trials.
• Experience managing globally distributed teams.
• Prior experience supporting or integrating with product or technology functions is highly desirable.
• Vision & Strategy: Ability to define and execute certification and site operations strategy aligned with corporate goals.
• Team Leadership: Builds effective, resilient teams and develops clinical and operational leaders.
• Change Enablement: Leads operational change and drives adoption of certification models and digital platforms.
• Metrics-Driven: Uses KPIs and performance data to guide continuous improvement.
• Stakeholder Management: Strong cross-functional collaboration across delivery, technology, and clinical teams.
• Culture & Influence: Sets the tone and leads by example in promoting company values and consistent operational standards.

• Travel between corporate locations, client sites, and industry events as required for leadership and client engagement.

Emmes Group: Building a better future for us all.

OptymEdge is part of the The Emmes Group. Emmes is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

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The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

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