Sr. Manager, Clinical Process Engineer

Purpose statement
Lead the design, optimization, and sustainment of clinical business processes across multiple functional domains to enable operational excellence, regulatory compliance, and scalable innovation within Clinical Development Operations. The Senior Manager, Clinical Process Engineer operates with significant independence, driving cross-functional alignment and translating complex, ambiguous business challenges into fit-for-purpose process solutions. This role shapes how process engineering work gets done across the function and builds the credibility and relationships needed to influence without authority.
Major responsibilities
Lead end-to-end process design and optimization across multiple clinical domains or workstreams simultaneously, managing ambiguity and competing priorities with minimal direction.
Serve as a primary process engineering resource for BPOs and functional leaders, advising on process strategy, design decisions, and tradeoffs.
Develop and govern process maps, work instructions, SOP-aligned content, and documentation standards across assigned domains; ensure consistency and scalability across teams.
Lead comprehensive current-state assessments and multi-variable process analyses to surface systemic issues, prioritize improvement opportunities, and recommend enterprise-aligned solutions.
Design and lead complex process design workshops across multi-stakeholder environments, including navigating competing interests, driving to decisions, and managing escalations appropriately.
Ensure process designs are built for inspection readiness, quality by design, and long-term operational sustainability; proactively identify and mitigate compliance risk embedded in process.
Lead process-to-system translation efforts, partnering with technology teams, business system owners, and program leadership on requirements, UAT, and readiness.
Define and implement process performance frameworks; recommend KPIs and instrumentation strategies; present findings and improvement recommendations to functional leadership.
Maintain and continuously improve controlled documentation practices across a domain; contribute to governance standards and documentation policy development.
May manage 0–4 direct reports; responsible for performance management, development planning, and building a high-performing, accountable team culture.
Bachelor's degree in engineering, life sciences, business, or a related field required; advanced degree preferred.
Lean Six Sigma certification required; Green Belt or Black Belt preferred.
Minimum 7 years of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment (GxP, clinical development, quality systems, or similar).
Strong knowledge of clinical development operations and associated regulatory, inspection, and quality expectations.
Expert proficiency in process mapping, documentation methods, and tools; demonstrated ability to develop scalable process artifacts and standards across teams.
Proven ability to lead complex, multi-stakeholder workshops and drive cross-functional alignment to decisions under ambiguity.
Advanced analytical skills (e.g., root cause analysis, multi-variable risk assessment, process performance analysis); ability to translate data into strategic recommendations.
Demonstrated experience leading process-to-system initiatives, including requirements definition, UAT strategy, and system readiness.
Executive-level written and verbal communication skills; able to present complex process topics to senior stakeholders with clarity and confidence.
Track record of managing multiple high-priority workstreams in a matrixed, global environment with high accountability and independent judgment.
Key stakeholders
BPOs, Process Experts, and functional leaders.
Clinical Development Operations senior leadership and operational teams.
Process Excellence / process architecture and governance leads.
Quality, compliance, and inspection readiness leadership.
Change engagement, learning, and training partners.
Technology and business system leaders.
Cross-functional governance forums and program leadership teams.

Employment type
Full-time

Work arrangement
Hybrid