Senior Manager, Clinical Operations – Clinical Process Owner

About This Opportunity

We are representing a confidential clinical research organization seeking a Senior Manager, Clinical Operations – Clinical Process Owner to work remotely in Poland. This is a strategic individual contributor role focused on process governance, harmonization, and continuous improvement across clinical trial operations.

Our client operates globally in the clinical research services sector, supporting therapeutic development from early-stage trials through regulatory approval. They maintain expertise in oncology and rare disease programs.

Responsibilities

• Serve as the Clinical Process Owner for clinical operations processes, ensuring governance, accountability, lifecycle management, and cross-regional alignment
• Lead development, review, harmonization, implementation, and maintenance of clinical operations SOPs, work instructions, tools, templates, and documentation
• Identify and resolve process gaps, duplication, inconsistencies, and unnecessary complexity to establish clear, practical, and scalable workflows
• Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, and stakeholder feedback into effective process solutions
• Lead cross-functional process governance and decision-making, partnering with 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, communication, adoption monitoring, and effectiveness evaluation
• Act as a senior subject matter expert for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement activities, and business development support
• Provide clinical operations input for proposals, budgets, and client presentations

What We're Looking For

Required:

• Bachelor's degree in life sciences, healthcare, clinical research, business, or 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 through implementation and 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

Preferred:

• Demonstrated experience owning or leading development, harmonization, implementation, and lifecycle management of clinical operations SOPs and controlled documentation
• Experience with process mapping, change management, Lean, or continuous improvement methodologies
• Expert understanding of clinical operations processes and cross-functional interfaces
• Ability to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally practical processes

How We Work With You

When you apply through Get A Job.ai, our talent team will review your qualifications and conduct an initial screening. If there's a strong match, we will submit your profile to our client for consideration. Please do not contact the employer directly—we manage all coordination and communication on your behalf throughout the recruitment process.

Pay

The client offers 304,500 PLN to 456,700 PLN gross per annum, plus discretionary annual bonus, private medical insurance, MultiSport Card, life insurance, pension, home working allowance, and vacation. Geographic differentials and final compensation depend on experience, skills, and organizational needs.

Get A Job.ai is an equal opportunity recruiter. We welcome applicants from all backgrounds and work to ensure fair access to opportunities regardless of race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.