Senior Manager, Clinical Operations - Clinical Process Owner

Pfm; Belgique; À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

Precision Medicine Group seeks a Senior Manager, Clinical Operations – Clinical Process Owner to govern and harmonize processes across regions. You will own SOPs, work instructions, tools, and documentation, driving simplification and scalable practices.

This senior SME collaborates with QA, Regulatory, PM, Data Management, and others to ensure compliant, practical processes and supports audits and CAPAs. You will lead change management, training, and stakeholder engagement while contributing to

Qualifications

• Bachelor's degree or equivalent in life sciences, healthcare, or related.
• 5+ years in clinical research or operations within CRO/pharma.
• Experience leading cross-functional/global process improvements.
• Strong knowledge of trial operations, monitoring, site management.
• Familiarity with ICH-GCP and regulatory expectations.

Responsabilités

• Govern Clinical Operations processes and lifecycle documentation.
• Lead SOP/work instruction development and maintenance.
• Identify gaps and simplify processes for scalability.
• Translate regulatory requirements into practical processes.
• Lead cross-functional governance and change management.

Connaissances

Cross-functional leadership

Process improvement

SOP development

Regulatory knowledge

ICH-GCP

Formation

Bachelor's degree in life sciences

Description du poste

Position Summary:

The Senior Manager, Clinical Operations – Clinical Process Owner is responsible for leading the governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. The 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, the role ensures that processes are compliant, practical, scalable, and consistently applied. As a senior Clinical Operations SME, the role also supports audits, inspections, CAPAs, strategic initiatives, and business development activities where Clinical Operations process expertise is required. This is an individual contributor leadership role requiring influence across functions, regions, and seniority levels. The role may lead cross-functional working groups, process teams, and strategic improvement initiatives.

Essential functions of the job include but are not limited to:

• 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 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.

Qualifications:

Minimum Required:

• 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:

• Demonstrated experience owning or leading the development, harmonization, implementation, and lifecycle management of 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.
• Ability to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally practical processes.

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease.

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