Senior Clinical Operations Process Excellence Lead Remote

Precision Medicine Group; Warszawa; On-site; PLN 305,000 - 457,000; Full time

Benefits offered by this job

Discretionary annual bonus

Private medical insurance

MultiSport Card

Life insurance

Pension

Home working allowance

Vacation

Among other benefits

Job summary

Precision for Medicine is seeking a Senior Manager, Clinical Operations to lead governance and continuous improvement of processes across regions. This individual contributor role drives SOP lifecycle management, cross‑functional collaboration, and alignment with regulatory standards.

This role is remote for Poland with potential cross-border collaboration; eligible for a discretionary annual bonus and comprehensive benefits.

Qualifications

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field; equivalent experience may be considered.
• 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.

Responsibilities

• 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.

Skills

Leadership

Cross-functional collaboration

Process improvement

Regulatory knowledge

Influence stakeholders

Education

Bachelor’s degree in life sciences or related field

Job description

Precision for Medicine is seeking a Senior Manager, Clinical Operations to lead governance and continuous improvement of processes across regions. This individual contributor role drives SOP lifecycle management, cross‑functional collaboration, and alignment with regulatory standards.

This role is remote for Poland with potential cross-border collaboration; eligible for a discretionary annual bonus and comprehensive benefits.