The Senior Manager, Process Optimization within the Center of Excellence (CoE) for Trial Operations, under the direction of the Associate Director/Director, Clinical Operations, is responsible for executing strategic initiatives that enhance operational efficiency, quality, and scalability across clinical trial execution. This role focuses on designing, implementing, and optimizing processes, tools, and systems that support global clinical operations. The Senior Manager will collaborate cross-functionally to drive continuous improvement, standardization, and innovation, ensuring alignment with regulatory requirements and organizational goals. This role act as a key contributor in advancing operational excellence across the clinical development portfolio.

Key Responsibilities:

Process Optimization & Innovation

• Implement process improvement initiatives across clinical operations and Clinical Management.
• Evaluate existing workflows and systems to identify inefficiencies and recommend scalable, compliant solutions.
• Proactively engage stakeholders to gather insights and feedback, identifying opportunities to drive optimization of Clinical Management and cross-functional processes related to trial conduct that support operational efficiency and quality.
• Facilitate the development of process maps, SOPs, work instructions, and training materials to support optimized operations.

Center of Excellence Leadership

• Support adoption of standardized processes and best practices across global teams developed by the Clinical Operations CoE .
• Act as a subject matter expert (SME) in operational excellence, providing guidance and mentorship to cross-functional stakeholders.
• Document processes and contribute to training materials as needed to promote a culture of innovation and quality.

Performance Measurement & Analytics

• Define and monitor key performance indicators (KPIs) and metrics to assess process effectiveness and operational health.
• Analyze performance data to identify trends, gaps, and opportunities for improvement.
• Prepare analyses and summaries and support with present findings and recommendations to senior leadership to inform strategic decision-making.

Cross-Functional Collaboration

• Partner with cross-functional stakeholders across applicable departments to ensure alignment and integration of process improvements.
• Collaborate on the development and refinement of joint processes, tools, and systems to enhance operational efficiency and compliance.
• Support cross-functional working groups and governance forums focused on operational excellence.
• Partner with external service providers (e.g., CROs, technology vendors, consultants) to align on process optimization goals and ensure consistent execution across outsourced activities.

Change Management & Stakeholder Engagement

• Support with the developing and executing of change management strategies to support adoption of new processes and systems.
• Engage stakeholders at all levels to gather feedback, build consensus, and ensure successful implementation of initiatives.
• Foster stakeholder engagement through transparent communication, training, and support to drive behavioral change and long-term adoption.
• Implement effectiveness checks (e.g., post-implementation assessments, stakeholder feedback loops, performance audits) to evaluate the success of change initiatives.
• Use data-driven insights to refine change strategies and ensure continuous improvement.
• Maintain a continuous improvement roadmap aligned with organizational priorities and regulatory expectations.

Compliance & Quality Assurance

• Ensure all process optimization efforts comply with GCP, ICH guidelines, and applicable regulatory requirements.
• Collaborate with internal teams to support QMS CAPA implementation related to operational process improvements identified via audits and inspections as applicable.

Qualifications/Required:

• Bachelor’s degree in life sciences, business, or related field (advanced degree preferred).
• Minimum 6+ years of experience in clinical operations, process improvement, or operational excellence within the pharmaceutical or biotech industry.
• Strong knowledge of clinical trial processes, regulatory requirements, and industry best practices.
• Proven experience in process design, Lean Six Sigma, or similar methodologies (certification preferred).
• Excellent analytical, project management, and communication skills.
• Demonstrated ability to work independently to lead cross-functional initiatives and drive organizational change.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Willingness to travel as required.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .

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