Senior Manager, Process Optimization

Otsuka•Princeton, NJ

About The Position

The Senior Manager, Process Optimization is part of the Center of Excellence (CoE) for Trial Operations and, under the direction of the Associate Director/Director, Clinical Operations, executes strategic initiatives that enhance efficiency, quality, and scalability across clinical trial execution. The role designs, implements, and optimizes processes, tools, and systems for global clinical operations, collaborating across functions to advance continuous improvement, standardization, and innovation in alignment with regulatory requirements and organizational goals. The position supports adoption of standardized processes and best practices, contributes subject-matter expertise in operational excellence, and measures process effectiveness through performance indicators and analytics. It also supports cross-functional and external-provider collaboration, change management, stakeholder engagement, and continuous-improvement planning. Process optimization work must comply with GCP, ICH guidelines, and applicable regulatory requirements.

Requirements

Bachelor’s degree in life sciences, business, or a related field.
At least 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.
Excellent analytical, project management, and communication skills.
Ability to work independently, lead cross-functional initiatives, and drive organizational change.
Proficiency in Microsoft Office, including Outlook, Word, Excel, and PowerPoint.
Willingness to travel as required.

Nice To Haves

Advanced degree preferred.
Lean Six Sigma or similar methodology certification preferred.

Responsibilities

Implement process improvement initiatives across clinical operations and Clinical Management.
Evaluate workflows and systems to identify inefficiencies and recommend scalable, compliant solutions.
Engage stakeholders to gather insights and identify optimization opportunities for Clinical Management and cross-functional trial-conduct processes.
Facilitate development of process maps, SOPs, work instructions, and training materials.
Support adoption of standardized processes and best practices developed by the Clinical Operations CoE across global teams.
Provide subject-matter expertise, guidance, and mentorship in operational excellence to cross-functional stakeholders.
Document processes and contribute to training materials to promote innovation and quality.
Define and monitor 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 presentation of findings and recommendations to senior leadership.
Partner with cross-functional stakeholders to align and integrate process improvements.
Collaborate on development and refinement of joint processes, tools, and systems to improve efficiency and compliance.
Support cross-functional working groups and governance forums focused on operational excellence.
Partner with CROs, technology vendors, consultants, and other external service providers to align process optimization goals and execution across outsourced activities.
Support development and execution of change management strategies for adoption of new processes and systems.
Gather stakeholder feedback, build consensus, and support successful initiative implementation.
Promote stakeholder engagement through transparent communication, training, and support for behavioral change and long-term adoption.
Implement effectiveness checks, such as post-implementation assessments, stakeholder feedback loops, and performance audits.
Use data-driven insights to refine change strategies and support continuous improvement.
Maintain a continuous improvement roadmap aligned with organizational priorities and regulatory expectations.
Ensure 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 through audits and inspections, as applicable.