Global Clinical Operations Process Owner

Precision For Medicine; Paris; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Precision for Medicine is seeking a Senior Manager, Clinical Operations – Clinical Process Owner to lead governance, harmonization, and continuous improvement of processes across the organization. You will own SOPs, work instructions, templates, and related documentation while ensuring compliance and scalability.

This individual contributor role requires cross-functional influence across regions and functions, with responsibilities spanning audits, CAPAs, and strategic initiatives where clinical

Qualifications

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field.
• 5+ years of 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.

Responsabilités

• 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 to establish clear, practical, and scalable ways of working.
• 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, partnering with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other relevant 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, as required, including providing Clinical Operations input for proposals, budgets, contracts, and bid defense meetings, and representing Clinical Operations process capabilities, delivery models, and operational strengths to prospective clients.

Connaissances

Cross-functional leadership

Influence stakeholders

Process improvement

Change management

Lean

ICH-GCP knowledge

Formation

Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field

Description du poste

Precision for Medicine is seeking a Senior Manager, Clinical Operations – Clinical Process Owner to lead governance, harmonization, and continuous improvement of processes across the organization. You will own SOPs, work instructions, templates, and related documentation while ensuring compliance and scalability.

This individual contributor role requires cross-functional influence across regions and functions, with responsibilities spanning audits, CAPAs, and strategic initiatives where clinical