Senior Manager, Clinical Operations – Clinical Process Owner

Position Overview

We are representing a confidential clinical research organization seeking a Senior Manager, Clinical Operations – Clinical Process Owner to join their team on a fully remote basis. This senior individual contributor role requires you to lead governance, harmonization, and continuous improvement of Clinical Operations processes across the organization.

You will own the development, alignment, and lifecycle management of Clinical Operations SOPs, work instructions, tools, templates, and related process documentation. Working cross-functionally and across regions, you will ensure that processes are compliant, practical, scalable, and consistently applied throughout the business.

Responsibilities

• Serve as the Clinical Process Owner for Clinical Operations processes, ensuring effective governance, clear accountability, lifecycle management, and alignment across regions and functions
• Lead the development, review, harmonization, implementation, and maintenance of Clinical Operations SOPs, work instructions, tools, templates, and related documentation
• Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity to establish clear, practical, and scalable ways of working
• Translate regulatory requirements, ICH-GCP principles, quality standards, audit and inspection findings, CAPAs, operational data, and stakeholder feedback into effective process solutions
• Lead and represent cross-functional process governance and decision-making, partnering with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other relevant functions
• Lead process implementation and change management, including impact assessment, stakeholder engagement, training and communication requirements, adoption monitoring, and evaluation of process effectiveness
• Act as a senior Clinical Operations subject matter expert for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement activities, and business development support as required

What We're Looking For

Required Qualifications:

• Bachelor's degree in life sciences, healthcare, clinical research, business, or a related field; equivalent experience may be considered
• At least 5+ years of progressive clinical research or clinical operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment
• Proven experience leading complex cross-functional or global process improvement initiatives from assessment and design through implementation and effectiveness evaluation within a CRO environment
• Strong knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes
• Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness principles
• Demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization

Preferred Qualifications:

• Demonstrated experience owning or leading the development, harmonization, implementation, and lifecycle management of Clinical Operations SOPs, work instructions, and related controlled documentation
• Experience with process mapping, change management, Lean, or continuous improvement methodologies
• Expert understanding of Clinical Operations processes and their cross-functional interfaces
• Ability to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally practical processes

How We Work With You

Our talent team at Get A Job.ai will guide you through the entire process. First, you'll apply through our platform at getajob.ai. One of our experienced recruiters will screen your application and conduct an initial conversation to understand your background and career goals. If there's a strong match, we'll submit your profile to our client for consideration. Please note that you should not contact the client directly—we will manage all communications and advocate on your behalf throughout the selection process.

Pay

Compensation details will be discussed during the screening process with our recruiting team.

Equal Employment Opportunity: Get A Job.ai is committed to creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, or any other protected characteristic.