Senior Clinical Operations Process Owner

Pfm; United States; On-site; USD 147,000 - 221,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings plan

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group in the United States seeks a Senior Manager, Clinical Operations – Clinical Process Owner to govern and harmonize processes across regions. You will own SOP lifecycle, develop tools and templates, and lead cross-functional teams to ensure compliant, scalable workflows.

The role requires strong experience in clinical operations, regulatory requirements, and CAPAs, with a track record of driving process improvements in a matrix organization.

Qualifications

• Bachelor’s degree or equivalent experience required.
• 5+ years of progressive clinical research or clinical operations experience in CRO/pharma/biotech/global outsourcing.
• Proven lead experience in cross-functional or global process-improvement initiatives.
• Strong knowledge of clinical trial operations, monitoring, site management, and cross-functional delivery.

Responsibilities

• Serve as Clinical Process Owner for governance and lifecycle management of processes across regions and functions.
• Lead development, review, harmonization, and maintenance of SOPs, work instructions, tools, and documentation.
• Identify and resolve process gaps, duplication, inconsistencies, and complexity to simplify workflows.
• Translate regulatory requirements, ICH-GCP, quality standards, audit findings, and CAPAs into practical solutions.
• Lead cross-functional governance, engaging with QA, Regulatory, PM, Data Management, Biostatistics, Medical, Training, and others.
• Lead process implementation and change management including impact assessment, stakeholder engagement, training, and adoption monitoring.
• Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings.

Skills

Cross-functional leadership

Influence stakeholders

Process improvement

Change management

Strategic thinking

Education

Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field

Job description

Precision Medicine Group in the United States seeks a Senior Manager, Clinical Operations – Clinical Process Owner to govern and harmonize processes across regions. You will own SOP lifecycle, develop tools and templates, and lead cross-functional teams to ensure compliant, scalable workflows.

The role requires strong experience in clinical operations, regulatory requirements, and CAPAs, with a track record of driving process improvements in a matrix organization.