Senior Manager, Clinical Operations - Clinical Process Owner

Precisionmedicinegroup · RemoteRemotesenior

In short

▸Líder en procesos clínicos globales, responsable de estandarizar y mejorar documentos y procedimientos.
▸Trabaja en equipo con múltiples áreas y regiones para asegurar cumplimiento, eficiencia y escalabilidad en operaciones clínicas.
▸Es experto clave en auditorías, inspecciones, propuestas comerciales y mejora continua en entornos de CRO.

Required for collaboration with global teams and documentation review.

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What they ask for

✓5+ años de experiencia progresiva en operaciones clínicas en CRO, farmacéutico o biotecnológico.
✓Experiencia comprobada liderando iniciativas globales de mejora de procesos.
✓Conocimiento sólido de ICH-GCP, normativas regulatorias y gestión de calidad.
✓Habilidad para influir en organizaciones matriciales y resolver conflictos de requerimientos.
✓Experiencia en gestión del ciclo de vida de SOPs, guías, herramientas y plantillas.
✓Capacidad para representar procesos clínicos en auditorías, propuestas comerciales y reuniones estratégicas.

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SOPswork instructionstoolstemplatesprocess documentationICH-GCPregulatory expectationsquality standardsaudit and inspection findingsCAPAs

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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 C

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