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Precision for Medicine seeks a Senior Manager, Clinical Operations to lead governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. This individual contributor leadership role owns the development, simplification, alignment, and lifecycle management of Clinical Operations SOPs, work instructions, tools, templates, and related process documentation. Working cross-functionally and across regions (UK, Hungary, Poland, Romania, Serbia, Slovakia), the role ensures processes are compliant, practical, scalable, and consistently applied.
Key responsibilities include serving as Clinical Process Owner for Clinical Operations, ensuring effective governance and clear accountability across regions and functions. You will lead development, review, harmonization, implementation, and maintenance of Clinical Operations SOPs and documentation. The role identifies and resolves process gaps, duplication, inconsistencies, and unnecessary complexity to establish clear, practical, scalable ways of working.
You will translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, operational data, and stakeholder feedback into effective process solutions. Leading cross-functional process governance and decision-making, you will partner with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other functions. The role leads process implementation and change management, including impact assessment, stakeholder engagement, training, adoption monitoring, and effectiveness evaluation.
As a senior Clinical Operations SME, you will support strategic initiatives, audits, inspections, CAPAs, process assessments, and business development activities, providing Clinical Operations input for proposals, budgets, contracts, and representing Clinical Operations capabilities to prospective clients.
Required: Bachelor's degree in life sciences, healthcare, clinical research, business, or related field (equivalent experience considered). Minimum 5+ years 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. Strong knowledge of clinical trial operations, clinical monitoring, site management, ICH-GCP, regulatory expectations, and quality standards. Demonstrated ability to influence stakeholders, facilitate decisions, and drive outcomes in matrix organizations.
Preferred: Experience owning or leading development 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.
