Global Clinical Operations Process Owner

Precisionmedicinegroup; 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 is seeking an Senior Manager, Clinical Operations – Clinical Process Owner to lead governance and harmonization of processes across the organization. You will own SOPs, work instructions, and templates, ensuring compliant, scalable workflows while supporting audits and strategic initiatives.

You will collaborate with QA, Regulatory, PM, Data Management, and other functions to streamline operations and drive improvements.

Qualifications

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field.
• 5+ years of progressive clinical research or clinical operations experience.
• Experience leading complex cross-functional or global process improvement initiatives.
• Strong knowledge of clinical trial operations, 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 and drive outcomes in a matrix organization.

Responsibilities

• Serve as the Clinical Process Owner for governance, lifecycle management, and alignment of Clinical Operations processes across regions and functions.
• Lead development, review, harmonization, implementation, and maintenance of SOPs, work instructions, tools, templates, and related documentation.
• Identify and resolve process gaps, duplication, inconsistencies, and unnecessary complexity to establish clear, practical processes.
• Translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, and stakeholder feedback into effective process solutions.
• Lead cross-functional process governance and decision-making with Clinical Operations, QA, Regulatory, PM, Data Management, Biostatistics, Medical, Training, and other functions.
• Oversee change management, impact assessment, training, engagement, and adoption monitoring to evaluate process effectiveness.
• Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings, representing capabilities to prospective clients.

Skills

Cross-functional leadership

Regulatory knowledge

Process improvement

Stakeholder influence

GCP/ICH knowledge

Education

Bachelor’s degree in life sciences or related field

Job description

Precision Medicine Group is seeking an Senior Manager, Clinical Operations – Clinical Process Owner to lead governance and harmonization of processes across the organization. You will own SOPs, work instructions, and templates, ensuring compliant, scalable workflows while supporting audits and strategic initiatives.

You will collaborate with QA, Regulatory, PM, Data Management, and other functions to streamline operations and drive improvements.