Senior Manager, Clinical Operations - Clinical Process Owner

Precisionmedicinegroup · RemoteRemotosenior

En corto

▸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.

En ~1 minuto te damos: quién te entrevista, las preguntas probables con respuestas desde tu CV, y tu CV adaptado a esta vacante. Gratis, sin tarjeta.

🎧¿Llegás a la entrevista? Llevá el copiloto. Nuestra extensión escucha la entrevista en vivo y te muestra anclas de 3-4 palabras desde tu CV y tu preparación — mirás, conectás, hablás. Gratis. Ver la extensión →

¿Qué piden?

✓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.

¿No cumplís todo? Es lo normal — tu dossier gratis te dice qué gaps tenés y cómo cubrirlos en la entrevista.

SOPswork instructionstoolstemplatesprocess documentationICH-GCPregulatory expectationsquality standardsaudit and inspection findingsCAPAs

¿A quién escribirle en Precisionmedicinegroup?

Tu dossier gratis identifica a las personas que te entrevistarían — con su background, qué valoran y cómo escribirles para destacar antes de aplicar.

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

No apliques sin prepararte

Investigamos quién te entrevista, adaptamos tu CV y te ensayamos en vivo — gratis la primera.