Senior Clinical Operations Process Owner - Global, Remote

Precision Medicine Group; Poland; Remote; 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

Job summary

Precision for Medicine Group is seeking a Senior Manager, Clinical Operations to drive governance, harmonization, and lifecycle management of SOPs, work instructions, tools, and templates across regions.

The role acts as a senior SME, collaborating with Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other functions, including supporting audits and CAPAs.

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 CRO/pharma/global outsourcing.
• Experience leading cross-functional/global process improvement initiatives from assessment to implementation.
• Strong knowledge of clinical trial operations, site management, and cross-functional trial delivery processes.
• Strong knowledge of ICH‑GCP, regulatory expectations, quality standards, and inspection readiness principles.
• Ability to influence stakeholders and drive outcomes in a matrix organization.

Responsibilities

• Serve as the Clinical Process Owner for Clinical Operations processes with governance and lifecycle management.
• Lead development, review, harmonization, and maintenance of SOPs, work instructions, tools, and templates.
• Identify and resolve process gaps and unnecessary complexity for scalable operating models.
• Translate regulatory requirements and audit findings into effective process solutions.
• Lead cross-functional governance and decision-making across regions and functions.
• Lead change management, training, adoption monitoring, and measurement of process effectiveness.
• Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings.

Skills

Cross-functional leadership

Stakeholder influence

Process improvement

Clinical operations

ICH-GCP knowledge

Education

Bachelor’s degree or equivalent

Job description

Precision for Medicine Group is seeking a Senior Manager, Clinical Operations to drive governance, harmonization, and lifecycle management of SOPs, work instructions, tools, and templates across regions.

The role acts as a senior SME, collaborating with Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other functions, including supporting audits and CAPAs.