Senior Manager, Clinical Operations – Clinical Process Owner

This is a fully remote position, open to applicants in Poland, +5 more countries.

📋 Description

• Act as the Clinical Process Owner for Clinical Operations processes, ensuring robust governance, defined accountability, lifecycle management, and alignment across various regions and functions.

• Oversee the creation, evaluation, standardization, execution, and upkeep of Clinical Operations SOPs, work instructions, tools, templates, and associated documentation.

• Detect and rectify process deficiencies, redundancies, inconsistencies, conflicting requirements, and unnecessary complexities.

• Convert regulatory stipulations, ICH-GCP principles, quality benchmarks, audit and inspection results, CAPAs, operational data, and stakeholder insights into effective process solutions.

• Lead and represent cross-functional process governance and decision-making alongside Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other departments.

• Direct process implementation and change management, including impact assessments, stakeholder engagement, training and communication needs, adoption tracking, and evaluation of process effectiveness.

• Serve as a senior Clinical Operations Subject Matter Expert for strategic initiatives, audits, inspections, CAPAs, process evaluations, operational enhancement activities, and business development assistance.

• Offer Clinical Operations insights for proposals, budgets, contracts, and bid defense meetings, and showcase Clinical Operations process capabilities to potential clients.

⛳️ Requirements

• A Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related discipline; equivalent experience may be accepted.

• A minimum of 5+ years of advancing clinical research or clinical operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing setting.

• Demonstrated experience in leading intricate cross-functional or global process improvement projects from assessment and design through to implementation and effectiveness evaluation within a CRO environment.

• Solid understanding of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes.

• Comprehensive knowledge of ICH-GCP, regulatory expectations, quality standards, and principles of inspection readiness.

• Proven ability to influence stakeholders, facilitate decision-making, resolve conflicting requirements, and drive outcomes within a matrix organization.

• Established experience owning or leading the development, standardization, execution, and lifecycle management of Clinical Operations SOPs, work instructions, and related controlled documentation.

• Familiarity with process mapping, change management, Lean, or continuous improvement methodologies.

• In-depth understanding of Clinical Operations processes and their cross-functional interactions.

• Capability to interpret regulatory and quality requirements and convert them into clear, proportionate, and operationally practical procedures.

🏝️ Benefits

• Discretionary annual bonus

• Private medical insurance

• MultiSport Card

• Life insurance

• Pension

• Home working allowance

• Vacation