Senior Manager, Clinical Operations - Clinical Process Owner

pfm; Poland; On-site; PLN 360,000 - 480,000; Full time

Job summary

pfm is seeking a Senior Manager, Clinical Operations to lead governance, harmonization, and improvement of processes across regions. You will own SOPs, work instructions, tools and templates, ensuring compliance, practicality, and scalability.

This individual contributor role requires cross-functional collaboration with QA, Regulatory, PM, Data Management, Biostatistics, Medical, Training, and other teams, and may lead process teams and strategic initiatives.

Qualifications

• Bachelor’s degree in life sciences or related field; equivalent experience may be considered.
• 5+ years of progressive clinical research or clinical operations experience in CRO/pharma/global outsourcing.
• Proven ability to lead cross-functional process improvement initiatives in CRO environments.
• Strong knowledge of clinical trial operations, ICH-GCP, and regulatory expectations.

Responsibilities

• Serve as Clinical Process Owner for governance, lifecycle management, and alignment across regions.
• Lead development, harmonization, and maintenance of SOPs, work instructions, tools, and templates.
• Identify gaps, duplication, and complexity; implement clear, scalable ways of working.
• Translate regulatory requirements and quality standards into effective process solutions.
• Lead cross-functional governance and decision-making; engage QA, Regulatory, PM, and more.
• Drive change management, training, adoption monitoring, and process effectiveness.
• Support audits, CAPAs, strategic initiatives, and business development with process input.

Skills

Stakeholder influence

Cross-functional collaboration

Regulatory knowledge

Process improvement

ICH-GCP understanding

Education

Bachelor's degree in life sciences or related field

Job description

Position Summary

The Senior Manager, Clinical Operations - Clinical Process Owner is responsible for leading the governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. The role owns the development, simplification, alignment, and lifecycle management of Clinical Operations SOPs, work instructions, tools, templates, and related process documentation. Working cross-functionally and across regions, the role ensures that processes are compliant, practical, scalable, and consistently applied. As a senior Clinical Operations SME, the role also supports audits, inspections, CAPAs, strategic initiatives, and business development activities where Clinical Operations process expertise is required. This is an individual contributor leadership role requiring influence across functions, regions, and seniority levels. The role may lead cross-functional working groups, process teams, and strategic improvement initiatives.

Essential functions of the job include but are not limited to:

• 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 to establish clear, practical, and scalable ways of working.
• 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, partnering with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other relevant 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, as required, including including providing Clinical Operations input for proposals, budgets, contracts, and bid defense meetings, and representing Clinical Operations process capabilities, delivery models, and operational strengths to prospective clients.

Qualifications

Minimum Required

• 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.

Preferred

• 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.

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, private medical insurance, M