Senior Manager, Clinical Operations – Clinical Process Owner

Jobtailor; Deutschland; Remote; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a Senior Clinical Operations professional to act as the Clinical Process Owner, ensuring governance, lifecycle management, and accountability across regions and functions. The role leads SOP development, harmonization, and documentation while identifying gaps and driving cross-functional improvements in CRO environments.

Strong regulatory knowledge and change management skills are essential.

Qualifikationen

• 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/global outsourcing.
• Experience leading cross-functional or global process improvement initiatives in CRO environments.
• Strong knowledge of clinical trial operations, ICH-GCP and inspection readiness.

Aufgaben

• Serve as the Clinical Process Owner for governance, accountability, lifecycle management across regions and functions.
• Lead development, harmonization, and maintenance of SOPs, work instructions, tools, templates, and docs.
• Identify and resolve process gaps, duplication, and complexity.
• Translate regulatory requirements and quality standards into practical processes.
• Lead cross-functional governance and decision-making with Clinical Ops, QA, Regulatory, Project Mgmt and more.
• Drive change management, training, adoption monitoring, and process effectiveness evaluation.
• Act as senior SME for strategic initiatives, audits, CAPAs, assessments, and business development support.
• Provide Clinical Ops input for proposals, budgets, contracts, and bid defense meetings.
• Lead cross-functional working groups and strategic improvement initiatives as needed.

Kenntnisse

Process Ownership

Stakeholder Influence

Cross-Functional Leadership

Lean / Continuous Improvement

Regulatory & Quality Knowledge

Ausbildung

Bachelor’s degree in life sciences or related field

Equivalent experience considered

Tools

SOP documentation tools

Jobbeschreibung

• 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
• 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 with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other 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
• Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings, and represent Clinical Operations process capabilities to prospective clients
• Lead cross-functional working groups, process teams, and strategic improvement initiatives as needed

Requirements

• 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
• 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

Core Competencies

Demonstrates expertise in Clinical Operations processes, including the development and implementation of SOPs, regulatory compliance, and cross-functional collaboration. Proven ability to lead process improvement initiatives and effectively engage stakeholders in a matrix organization.

Highest-signal resume keywords

• Clinical Operations Process Ownership
• Regulatory Compliance Expertise
• Cross-Functional Process Improvement
• SOP Development and Lifecycle Management
• Change Management and Stakeholder Engagement

Hard Skills

• Clinical Trial Operations
• Process Mapping
• Lean Methodologies
• Continuous Improvement
• ICH-GCP Knowledge
• Quality Standards Interpretation
• Clinical Monitoring
• Site Management
• Operational Effectiveness Evaluation
• Audit and Inspection Readiness

Soft Skills

• Stakeholder Influence
• Decision Facilitation
• Conflict Resolution
• Outcome-Driven Leadership
• Effective Communication

Industry Keywords

• Clinical Research
• CRO
• Pharmaceutical
• Biotechnology
• Global Clinical Outsourcing
• Process Governance
• Operational Improvement
• Bid Defense Meetings
• Cross-Functional Teams
• Strategic Initiatives