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Precision for Medicine is seeking a Senior Manager, Clinical Operations to lead governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. This individual contributor leadership 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, you will ensure processes are compliant, practical, scalable, and consistently applied.
Key responsibilities include serving as the Clinical Process Owner for Clinical Operations processes, ensuring effective governance and clear accountability across regions and functions. You will lead the development, review, harmonization, implementation, and maintenance of Clinical Operations SOPs and related documentation. The role involves identifying and resolving process gaps, duplication, inconsistencies, and unnecessary complexity to establish clear, practical, and scalable ways of working.
You will translate regulatory requirements, ICH-GCP principles, quality standards, audit findings, CAPAs, operational data, and stakeholder feedback into effective process solutions. The position requires leading 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.
Additional responsibilities include leading process implementation and change management, including impact assessment, stakeholder engagement, training and communication requirements, adoption monitoring, and effectiveness evaluation. You will act as a senior Clinical Operations subject matter expert for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvement activities, and business development support, including providing Clinical Operations input for proposals, budgets, contracts, and bid defense meetings.
Required qualifications include a Bachelor's degree in life sciences, healthcare, clinical research, business, or related field (equivalent experience may be considered), and at least 5+ years of progressive clinical research or clinical operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment. You must have 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, and demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization.
