Senior Manager, Clinical Operations

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Clinical Operations based in United States.

The Senior Manager, Clinical Operations will serve as a strategic process leader responsible for strengthening and harmonizing Clinical Operations practices across a global organization.

You will own the governance and lifecycle of key SOPs, work instructions, tools, templates, and process documentation.

Working across functions and regions, you will simplify complex workflows and ensure processes are compliant, practical, scalable, and consistently applied.

The role combines deep clinical operations expertise with cross-functional influence, requiring you to align stakeholders and drive meaningful process improvements.

You will translate regulatory expectations, quality standards, audit findings, and operational insights into effective and sustainable ways of working.

As a senior subject-matter expert, you will also contribute to audits, inspections, CAPAs, strategic initiatives, and business development activities.

This individual contributor leadership role offers the opportunity to shape global clinical operations standards while partnering with teams across a dynamic, matrixed environment

Accountabilities:

• Serve as the Clinical Operations Process Owner, establishing effective governance, accountability, lifecycle management, and alignment across regions and functions.
• Lead the development, review, harmonization, implementation, and ongoing maintenance of Clinical Operations SOPs, work instructions, tools, templates, and controlled documentation.
• Identify process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity, translating findings into clear, practical, and scalable solutions.
• Interpret regulatory requirements, ICH-GCP principles, quality standards, audit and inspection findings, CAPAs, operational data, and stakeholder feedback to improve Clinical Operations processes.
• Lead cross-functional process governance and facilitate decision-making in partnership with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other relevant teams.
• Lead process implementation and change management activities, including impact assessments, stakeholder engagement, communications, training requirements, adoption monitoring, and effectiveness evaluation.
• Establish and lead cross-functional working groups, process teams, and strategic improvement initiatives as required.
• Act as a senior Clinical Operations subject-matter expert for audits, inspections, CAPAs, process assessments, operational improvement programs, and strategic initiatives.
• Provide Clinical Operations process expertise for business development activities, including proposals, budgets, contracts, bid-defense meetings, and discussions with prospective clients.
• Represent Clinical Operations capabilities, delivery models, process maturity, and operational strengths to internal and external stakeholders.
• Promote continuous improvement and ensure that Clinical Operations processes remain aligned with evolving regulatory, quality, and business requirements.

Requirements:

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related discipline; equivalent relevant experience may also be considered.
• 5+ years of progressive experience in clinical research or Clinical Operations within a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment.
• Demonstrated experience leading complex, cross-functional, or global process improvement initiatives from assessment and design through implementation and effectiveness evaluation.
• Strong understanding of clinical trial operations, including clinical monitoring, site management, and cross-functional trial delivery processes.
• Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection-readiness principles.
• Proven experience developing, harmonizing, implementing, and managing the lifecycle of Clinical Operations SOPs, work instructions, and related controlled documentation is highly preferred.
• Experience with process mapping, change management, Lean, continuous improvement, or similar process optimization methodologies is advantageous.
• Expert understanding of Clinical Operations processes and their interfaces with other functions.
• Ability to interpret regulatory and quality requirements and translate them into clear, proportionate, practical operational processes.
• Strong stakeholder-management and influencing skills, with the ability to facilitate decisions, resolve conflicting requirements, and drive outcomes within a matrix organization.
• Excellent communication, facilitation, collaboration, and problem-solving capabilities.
• Ability to operate effectively across regions, functions, and levels of seniority while building alignment without relying solely on formal authority.
• Strong strategic thinking combined with a practical, execution-oriented approach to process improvement.

Benefits:

• Opportunity to take ownership of global Clinical Operations processes and directly influence operational quality and consistency.
• Senior individual-contributor leadership position with significant cross-functional and international visibility.
• Opportunity to work across Clinical Operations, Quality, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other specialized functions.
• Exposure to strategic initiatives, audits, inspections, CAPAs, process improvement programs, and business development activities.
• Opportunity to shape scalable, compliant, and efficient clinical research processes across a global organization.
• Collaborative, matrixed working environment with opportunities to influence stakeholders across regions and functions.
• Professional growth through involvement in high-impact clinical operations and organizational improvement initiatives.
• Competitive compensation and benefits package, subject to the applicable employment location and company policy.
• Eligibility for applicable healthcare, retirement, paid time off, and other employee benefits based on location and employment terms.