Senior Manager, Clinical Operations – Clinical Process Owner
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Job Description
Senior Manager owning Clinical Operations processes, SOPs, and governance at a global precision medicine research organization. Driving compliant, scalable process improvement across clinical research functions.
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
- 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 with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other 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 SME for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement activities, and business development support
- Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings
- Represent Clinical Operations process capabilities, delivery models, and operational strengths to prospective clients
- May lead cross-functional working groups, process teams, and strategic improvement initiatives
Requirements:
- 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: experience owning or leading the development, harmonization, implementation, and lifecycle management of Clinical Operations SOPs, work instructions, and related controlled documentation
- Preferred: experience with process mapping, change management, Lean, or continuous improvement methodologies
- Preferred: expert understanding of Clinical Operations processes and their cross-functional interfaces
- Preferred: ability to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally practical processes
Benefits:
- Remote work in the UK, Hungary, Poland, Romania, Serbia or Slovakia
- Regular full-time employment
- Equal opportunity employment
- Reasonable accommodation during the application process for individuals with disabilities
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