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Precision for Medicine seeks a Senior Manager, Clinical Operations to serve as Clinical Process Owner, leading governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. This is a senior individual contributor leadership role requiring influence across functions, regions, and seniority levels—not a traditional people-management position, but one that leads cross-functional working groups and strategic improvement initiatives.
Key responsibilities include: owning the development, simplification, alignment, and lifecycle management of Clinical Operations SOPs, work instructions, tools, templates, and process documentation; ensuring processes are compliant, practical, scalable, and consistently applied across regions; identifying and resolving process gaps, duplication, inconsistencies, and unnecessary complexity; translating regulatory requirements (ICH-GCP), quality standards, audit findings, and CAPAs into effective process solutions; leading cross-functional governance and decision-making with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, and Training functions; managing process implementation and change management including impact assessment, stakeholder engagement, training, adoption monitoring, and effectiveness evaluation; and serving as a senior Clinical Operations SME for strategic initiatives, audits, inspections, CAPAs, and business development support.
Required qualifications: Bachelor's degree in life sciences, healthcare, clinical research, business, or related field (or equivalent experience); 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 through implementation and evaluation; strong knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery; strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness; demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization.
Preferred qualifications include: demonstrated experience owning or leading development, harmonization, implementation, and lifecycle management of Clinical Operations SOPs and controlled documentation; experience with process mapping, change management, Lean, or continuous improvement methodologies; expert understanding of Clinical Operations processes and cross-functional interfaces; ability to interpret regulatory and quality requirements and translate them into clear, proportionate, operationally practical processes.
