Senior Manager, Clinical Operations

About This Opportunity

We are representing a confidential clinical research organization in their search for a Senior Manager, Clinical Operations. This is a remote position requiring a strategic leader who can drive process excellence across global clinical trial operations.

In this role, you will serve as the Clinical Process Owner, leading the governance and continuous improvement of clinical operations processes across the organization. You will be responsible for developing, harmonizing, and maintaining SOPs, work instructions, and process documentation while ensuring compliance with regulatory standards and operational effectiveness.

Responsibilities

• Own Clinical Operations process governance, lifecycle management, and cross-regional alignment
• Lead development, review, and maintenance of Clinical Operations SOPs, work instructions, tools, and templates
• Identify and resolve process gaps, duplication, and unnecessary complexity to establish scalable ways of working
• Translate regulatory requirements, ICH-GCP principles, quality standards, and audit findings into effective process solutions
• Lead cross-functional process governance partnering with Quality Assurance, Regulatory, Project Management, Data Management, and other functions
• Drive process implementation and change management including impact assessment, stakeholder engagement, training, and adoption monitoring
• Serve as senior Clinical Operations SME for strategic initiatives, audits, inspections, CAPAs, and business development support

What We're Looking For

Required Qualifications:

• Bachelor's degree in life sciences, healthcare, clinical research, business, or related field
• 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 through implementation and evaluation
• 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, and drive outcomes in a matrix organization

Preferred Qualifications:

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

How We Work With You

Candidates apply directly through Get A Job.ai. Our talent team will screen qualified candidates and coordinate submissions to our client. Once submitted, we will facilitate the interview process and support you through offer and onboarding. Please do not contact the client directly during this process.

Pay

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

Equal Employment Opportunity: Get A Job.ai is committed to fair and equitable hiring practices. We welcome applications from all qualified candidates regardless of race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.