Senior Manager, Clinical Operations - Clinical Process Owner

Precision For Medicine; Madrid; Presencial; EUR 90.000 - 125.000; Jornada completa

Descripción de la vacante

Precision for Medicine in Madrid is seeking a Senior Manager, Clinical Operations to lead governance, harmonization, and lifecycle management of SOPs and process documents. You will work across regions to ensure compliant, scalable processes and act as a senior SME for audits, CAPAs, and strategic initiatives.

The role requires cross-functional leadership, regulatory knowledge, and the ability to influence stakeholders in a matrix organization.

Formación

• Cross-functional leadership and stakeholder influence demonstrated.
• Strong knowledge of regulatory expectations (ICH-GCP) and quality standards.
• Experience leading cross-functional process improvement initiatives in CRO/biotech settings.

Responsabilidades

• Govern Clinical Operations processes with clear governance and lifecycle management across regions.
• Develop and maintain SOPs, work instructions, tools, templates, and documentation.
• Identify gaps, duplication, and complexity; implement practical, scalable processes.
• Represent Clinical Operations in audits/ CAPAs and strategic initiatives across functions.

Conocimientos

Cross-functional leadership

Influence stakeholders

Process improvement

Quality/regulatory knowledge

Educación

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

Herramientas

Lean methodology

Descripción del empleo

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 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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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

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