Senior Clinical Operations 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

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.