Senior Manager, Clinical Operations – Clinical Process Owner

Stellenbeschreibung:

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.