Senior Manager, Clinical Operations - Clinical Process Owner

Location: Remote in Hungary, Poland, Romania, Serbia, Slovakia, or the United Kingdom

Company

hirify.global provides global precision medicine clinical research services integrating clinical operations, laboratory expertise, and advanced data sciences across therapeutic development.

What you will do

• Own governance, accountability, alignment, and lifecycle management for Clinical Operations processes across regions and functions.
• Lead the development, harmonization, implementation, and maintenance of SOPs, work instructions, tools, templates, and controlled process documentation.
• Identify process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity, then design scalable improvements.
• Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, operational data, and stakeholder feedback into practical process solutions.
• Lead cross-functional governance, change management, stakeholder engagement, training, communication, adoption monitoring, and effectiveness evaluation.
• Support audits, inspections, CAPAs, strategic initiatives, process assessments, proposals, budgets, contracts, and bid defense activities as a Clinical Operations subject matter expert.

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.
• 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, cross-functional trial delivery, ICH-GCP, regulatory expectations, quality standards, and inspection readiness.
• Ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization.

Nice to have

• Experience owning or leading 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.

Culture & Benefits

• Remote work available from the listed European countries.
• Cross-functional collaboration across Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, and Training.
• Opportunity to contribute to clinical research programs from early development through approval, including oncology and rare disease studies.