Senior Clinical Operations Process Leader

Precision Medicine Group; Madrid; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Precision Medicine Group is a leading global precision medicine clinical research services organization. This Senior Manager, Clinical Operations – Clinical Process Owner will govern and harmonize processes across regions, owning SOPs, templates, tools, and documentation to ensure compliant, scalable operations.

You will drive cross-functional governance, change management, and strategic initiatives as an SME for audits, CAPAs, and proposals.

Formación

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field.
• 5+ years of progressive clinical research or clinical operations experience in CRO/pharma biotech or global clinical outsourcing.
• Proven experience leading complex cross-functional or global process improvement initiatives from assessment through implementation in 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.

Responsabilidades

• 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 SOPs, work instructions, tools, templates, and related documentation.
• Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity to establish clear, practical, scalable ways of working.
• Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, operational data, and stakeholder feedback into effective process solutions.
• Lead and represent cross-functional process governance and decision-making, partnering with multiple functions across regions.
• Lead process implementation and change management, including impact assessment, stakeholder engagement, training needs, adoption monitoring, and evaluation of effectiveness.
• Act as a senior Clinical Operations SME for strategic initiatives, audits, inspections, CAPAs, process assessments, and business development support.

Conocimientos

Stakeholder influence

Cross-functional collaboration

Process improvement

Regulatory knowledge

Audit support

Project management

ICH-GCP familiarity

Educación

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

Descripción del empleo

Precision Medicine Group is a leading global precision medicine clinical research services organization. This Senior Manager, Clinical Operations – Clinical Process Owner will govern and harmonize processes across regions, owning SOPs, templates, tools, and documentation to ensure compliant, scalable operations.

You will drive cross-functional governance, change management, and strategic initiatives as an SME for audits, CAPAs, and proposals.