Senior Manager, Clinical Operations

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

Position Summary

The Senior Manager, Clinical Operations – Clinical Process Owner is responsible for leading the governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. The role owns the development, simplification, alignment, and lifecycle management of Clinical Operations SOPs, work instructions, tools, templates, and related process documentation. Working cross-functionally and across regions, the role ensures that processes are compliant, practical, scalable, and consistently applied. As a senior Clinical Operations SME, the role also supports audits, inspections, CAPAs, strategic initiatives, and business development activities where Clinical Operations process expertise is required. This is an individual contributor leadership role requiring influence across functions, regions, and seniority levels. The role may lead cross-functional working groups, process teams, and strategic improvement initiatives.

Essential functions of the job include but are not limited to

• 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 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.

Qualifications

Minimum Required

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or a 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.
• 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.

Preferred

• Demonstrated experience owning or leading the development, harmonization, implementation, and lifecycle management of Clinical Operations SOPs, work instructions, and related controlled documentation.
• Experience with process mapping, change management, Lean, or continuous improvement methodologies.
• Expert understanding of Clinical Operations processes and their cross-functional interfaces.
• Ability to interpret regulatory and quality requirements and translate them into clear, proportionate, and operationally practical processes.

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$147,300 — $220,900 USD

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].

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