高级经理，临床运营 - 临床流程负责人
Senior Manager, Clinical Operations - Clinical Process Owner
职位概述：
临床运营高级经理 – 临床流程负责人负责领导整个组织内临床运营流程的治理、统一和持续改进。该职位负责临床运营SOP、操作指南、工具、模板及相关流程文档的开发、简化、对齐和生命周期管理。跨职能和跨地区工作，该职位确保流程符合规范、实用、可扩展且一致应用。作为高级临床运营专家，该职位还支持审计、检查、CAPA、战略计划和业务发展活动，当需要临床运营流程专业知识时提供支持。这是一个需要在各职能、地区和层级之间产生影响力的个人贡献型领导职位。该职位可能领导跨职能工作组、流程团队和战略改进项目。
主要职责包括但不限于：
- 作为临床运营流程的临床流程负责人，确保有效的治理、明确的责任归属、流程生命周期管理和跨地区及职能的对齐。
- 领导临床运营SOP、操作指南、工具、模板及相关文档的开发、审查、统一、实施和维护。
- 识别并解决流程缺口、重复、不一致、冲突要求和不必要的复杂性，建立清晰、实用且可扩展的工作方式。
- 将监管要求、ICH-GCP原则、质量标准、审计和检查发现、CAPA、运营数据和利益相关者反馈转化为有效的流程解决方案。
- 领导并代表跨职能流程治理和决策，与临床运营、质量保证、法规事务、项目管理、数据管理、生物统计、医学、培训和其他相关职能合作。
- 领导流程实施和变更管理，包括影响评估、利益相关者参与、培训和沟通需求、采用监控以及流程有效性的评估。
- 在战略计划、审计、检查、CAPA、流程评估、运营改进活动和业务发展支持中，作为高级临床运营专家提供支持，包括提供临床运营方面的输入
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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 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.
- At least 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 within a CRO environment.
- 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 for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease.
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