Senior Manager, Process Optimization

About the role

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.

Responsibilities

• 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.
• 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.
• 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.
• Partner with cross-functional stakeholders across applicable departments to ensure alignment and integration of process improvements.
• 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.
• 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.
• Implement effectiveness checks (e.g., post-implementation assessments, stakeholder feedback loops, performance audits) to evaluate the success of change initiatives.
• Maintain a continuous improvement roadmap aligned with organizational priorities and regulatory expectations.
• 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

• 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.

Pay

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity.

Schedule

TBD.

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.