Remote Senior Clinical Operations Lead – Process Owner

Precisionmedicinegroup; United States; Remote; USD 140,000 - 200,000; Full time

Job summary

Precision for Medicine is hiring a Senior Manager, Clinical Operations to join our team. This role leads governance, harmonization, and continuous improvement of Clinical Operations processes and documents across regions, ensuring compliance, practicality, and scalability.

The Senior Manager acts as a SME, supporting audits, CAPAs, and strategic initiatives, while collaborating with QA, Regulatory, PM, Data Management, Biostatistics, Medical, Training, and other functions.

Qualifications

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field; equivalent experience may be considered.
• At least 5+ years of progressive clinical research or clinical operations experience in CRO/pharma/global outsourcing.
• Proven experience leading cross-functional or global process improvement initiatives.

Responsibilities

• Serve as Clinical Process Owner for governance, lifecycle management of SOPs and related docs.
• Lead development, harmonization, and maintenance of SOPs, work instructions, tools and templates.
• Identify gaps, duplication, inconsistencies, and simplify processes for clear, scalable workflows.
• Translate regulatory requirements, ICH-GCP, quality standards into effective process solutions.
• Lead cross-functional governance and decision-making with multiple functions across regions.
• Drive process implementation, change management, training, stakeholder engagement, adoption monitoring.
• Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings.

Skills

Cross-functional collaboration

Influence stakeholders

Process optimization

Regulatory knowledge

Audit support

Education

Bachelor’s degree in life sciences/healthcare/clinical research

Job description

Precision for Medicine is hiring a Senior Manager, Clinical Operations to join our team. This role leads governance, harmonization, and continuous improvement of Clinical Operations processes and documents across regions, ensuring compliance, practicality, and scalability.

The Senior Manager acts as a SME, supporting audits, CAPAs, and strategic initiatives, while collaborating with QA, Regulatory, PM, Data Management, Biostatistics, Medical, Training, and other functions.