Senior Manager, Clinical Operations – Clinical Process Owner

About This Opportunity

We are representing a confidential contract research organization that is seeking a Senior Manager, Clinical Operations to lead process governance and continuous improvement initiatives. This is a fully remote role available to candidates based in the UK, Hungary, Poland, Romania, Serbia, or Slovakia.

As the Clinical Process Owner, you will be responsible for harmonizing clinical operations processes across a global organization, ensuring compliance with regulatory standards while driving operational excellence. This individual contributor leadership role requires you to influence stakeholders across functions and regions without direct reports.

Responsibilities

• Serve as the Clinical Process Owner, ensuring effective governance, accountability, and lifecycle management of clinical operations processes across all regions
• Lead development, review, harmonization, implementation, and maintenance of SOPs, work instructions, tools, templates, and related documentation
• Identify and resolve process gaps, duplication, inconsistencies, and unnecessary complexity to establish clear and scalable workflows
• Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, and CAPAs into practical process solutions
• Lead cross-functional process governance and decision-making, partnering with Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other functions
• Manage process implementation and change management, including impact assessment, stakeholder engagement, training coordination, and effectiveness evaluation
• Act as senior subject matter expert for strategic initiatives, audits, inspections, CAPAs, process assessments, and business development activities
• Provide clinical operations input for proposals, budgets, and contracts as needed

What We're Looking For

Required qualifications:

• Bachelor's degree in life sciences, healthcare, clinical research, business, or 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 through implementation and evaluation within a CRO setting
• 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 and 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 recruitment process. When you apply through our platform, a dedicated recruiter will conduct an initial screening to understand your background and career goals. We will then present qualified candidates to our client organization. Please do not contact the client directly—all communication and coordination will be managed through Get A Job.ai to ensure the best outcome for your candidacy.

Pay

Compensation details will be discussed during the screening process based on experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to creating an inclusive recruitment process. We welcome applicants from all backgrounds and do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other protected characteristic.