Senior Manager, Clinical Operations – Clinical Process Owner

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee the governance, harmonization, and ongoing enhancement of Clinical Operations processes throughout the organization.

• Take responsibility for the creation, simplification, alignment, and lifecycle management of Clinical Operations SOPs, work instructions, tools, templates, and relevant process documentation.

• Act as the Clinical Process Owner, ensuring effective governance, clear accountability, lifecycle management, and alignment across various regions and functions.

• Identify and address process gaps, redundancies, inconsistencies, conflicting requirements, and unnecessary complexities.

• Convert regulatory requirements, ICH-GCP principles, quality standards, audit and inspection outcomes, CAPAs, operational data, and stakeholder feedback into process solutions.

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

• Spearhead process implementation and change management, which includes impact assessments, stakeholder engagement, training, communication, adoption monitoring, and effectiveness evaluation.

• Serve as a senior Subject Matter Expert in Clinical Operations for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement efforts, and business development support.

• Contribute Clinical Operations insights for proposals, budgets, contracts, and bid defense meetings, while showcasing process capabilities to potential clients.

• Facilitate cross-functional working groups, process teams, and strategic improvement initiatives as necessary.

⛳️ Requirements

• 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 progressive experience in clinical research or clinical operations within a CRO, pharmaceutical, biotechnology, or global clinical outsourcing setting.

• Proven track record of leading complex cross-functional or global process improvement initiatives from assessment and design through to implementation and effectiveness evaluation within a CRO environment.

• In-depth knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes.

• Strong understanding of ICH-GCP, regulatory expectations, quality standards, and principles of inspection readiness.

• Demonstrated capacity to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes within a matrix organization.

• Proven experience in owning or leading the development, harmonization, implementation, and lifecycle management of Clinical Operations SOPs, work instructions, and related controlled documentation.

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

• Expert knowledge of Clinical Operations processes and their cross-functional interactions.

• Ability to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally feasible processes.

🏝️ Benefits

• Discretionary annual bonus

• Private medical insurance

• MultiSport Card

• Life insurance

• Pension

• Home working allowance

• Vacation