Clinical Trial Quality Control Manager – Site Oversight

🕒 Agosto 12

🏄 California – Remoto

🏄 California – Remote

💵 $140.000 - $160.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

👻 Score fantasma 0%

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Zai Lab

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2014

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $857.500.000 Post-IPO Equity em 2021-04

Healthcare • Biotechnology • Pharmaceuticals

A Zai Lab é uma empresa biofarmacêutica inovadora, orientada à pesquisa e em fase comercial, com sede na China e nos Estados Unidos. A empresa tem como foco levar medicamentos transformadores nas áreas de oncologia, imunologia, neurociência e doenças infecciosas a pacientes na China e em todo o mundo. Sua missão é oferecer tratamentos inovadores a pacientes com necessidades médicas não atendidas, causando um impacto significativo na saúde global.

Descrição

• Develop and maintain study-specific QC plans based on study progress, complexity, and risk assessment • Create and maintain QC tools, including checklists, templates, and trackers • Conduct risk-based, on-site QC visits to investigational sites • Assess protocol adherence and execution of critical study processes, including informed consent, protocol-required procedures, safety reporting, and essential document maintenance • Conduct in-house QC activities through remote or in-office reviews as needed • Evaluate site processes and documentation • Prepare QC Visit Reports documenting scope, observations, trends, and follow-up actions • Escalate significant compliance, patient safety, or data integrity concerns • Identify protocol deviations, recurring site-level issues, and operational risks • Support root cause analysis and corrective and preventive actions • Track QC findings and follow-up actions to closure • Contribute to cross-site and cross-study trend analysis • Support inspection readiness activities, including self-checks and targeted readiness reviews • Provide QC summaries and documentation to Clinical Operations leadership and study teams • Contribute to Clinical Operations training based on QC findings and site execution gaps • Incorporate lessons learned into training, guidance, and study team communications • Identify process improvement opportunities • Support implementation of SOPs and study processes through training and clarification

🎯 Requisitos

• Bachelor’s degree in medical science or a related field, with five years’ experience in clinical research, including hands-on quality-related activities such as QC oversight and inspection-related activities; or equivalent combination of higher education, training and experience • Deep knowledge and understanding of clinical trial processes and quality management • Strong working knowledge of ICH-GCP and applicable regulations and guidelines • Understanding of skills and knowledge required to deliver clinical studies, including international guidelines, study management, site management, and monitoring • Strong communication and influencing skills • Ability to analyze, interpret, and resolve complex issues • Strategic and objective thinking, creativity, innovation, and sound judgment • Commitment to high standards of integrity and ethics • Frequent travel to investigational sites required

🏖️ Benefícios

• Sign-on bonus • Restricted stock units • Discretionary awards • Medical benefits • Financial benefits • 401(k) eligibility • Paid vacation time • Paid sick time • Paid parental leave • Remote work arrangement