Senior Manager, Clinical Operations – Clinical Process Owner

Responsibilities

We are representing a confidential clinical research organization seeking a Senior Manager, Clinical Operations – Clinical Process Owner to lead the governance, harmonization, and continuous improvement of clinical operations processes. This is a remote, individual contributor leadership role requiring influence across functions, regions, and seniority levels.

In this position, you will:

• 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

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 partners with leading organizations to connect exceptional candidates with career-defining opportunities. When you apply through our platform, a dedicated recruiter will review your qualifications and conduct an initial screening. If there's a strong match, we will submit your profile to our client for consideration. Please note that all applications must go through Get A Job.ai—do not contact the client directly.

Pay

Compensation details will be discussed with qualified candidates during the screening process.

Get A Job.ai is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all candidates regardless of race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.