Senior Clinical Process Owner & Operations Lead

Precision Medicine Group; Amsterdam; On-site; EUR 90,000 - 130,000; Full time

Job summary

Precision Medicine Group is seeking a Senior Manager, Clinical Operations – Clinical Process Owner to drive governance, harmonization, and continuous improvement of processes across the organization. You will own SOPs, work instructions, tools, and templates, ensuring scalable, compliant operations across regions.

As a senior SME, you will support audits, CAPAs, strategic initiatives, and client-facing proposals, partnering with QA, Regulatory, PM, Data Management, Biostatistics, Medical, and

Qualifications

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field.
• At least 5+ years of progressive clinical research or clinical operations experience in a CRO/pharma environment.
• Proven experience leading complex cross-functional or global process improvement initiatives.
• Strong knowledge of clinical trial operations, monitoring, site management, and cross-functional trial delivery.
• Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness.
• Demonstrated ability to influence stakeholders and drive outcomes in a matrix organization.

Responsibilities

• Serve as the Clinical Process Owner for Clinical Operations processes, ensuring governance, clear accountability, lifecycle management, and alignment across regions and functions.
• Lead 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.

Skills

Clinical Operations

Cross-functional leadership

ICH-GCP

Regulatory knowledge

Process improvement

Audit readiness

Education

Bachelor’s degree in life sciences

Job description

Precision Medicine Group is seeking a Senior Manager, Clinical Operations – Clinical Process Owner to drive governance, harmonization, and continuous improvement of processes across the organization. You will own SOPs, work instructions, tools, and templates, ensuring scalable, compliant operations across regions.

As a senior SME, you will support audits, CAPAs, strategic initiatives, and client-facing proposals, partnering with QA, Regulatory, PM, Data Management, Biostatistics, Medical, and