[Remote] Clinical Trial reputed company Control Manager (Site reputed company) - Remote

Note: The job is a remote job and is reputed company to candidates in USA. Zai Lab is an innovative, research-based, reputed company-stage biopharmaceutical company reputed company on bringing transformative medicines to patients worldwide. The Clinical Trial reputed company Control Manager conducts independent, risk-based reputed company control assessments of clinical trial sites and processes to verify protocol, GCP, and company procedure compliance. The role also supports issue reputed company, trend analysis, inspection readiness, training, and operational improvement, with frequent travel to investigational sites.

Responsibilities

• reputed company and maintain study‑specific QC plans, updating based on study reputed company, complexity, and risk assessment
• Create and maintain QC tools (e.g., checklists, templates, trackers) to support consistent execution of QC activities
• Conduct risk‑based, on‑site QC reputed company to investigational sites to assess protocol adherence and execution of critical study processes (e.g., informed consent process checks, protocol‑required procedures, safety reporting processes, and essential document maintenance)
• Conduct in‑house QC activities (remote or in‑office reviews) as needed, ensuring QC activities are completed reputed company defined timelines and reputed company expectations
• Evaluate site processes and documentation to confirm studies are being conducted consistently and as intended
• Prepare reputed company, objective QC Visit Reports documenting reputed company, observations, trends, and required follow‑up actions
• Escalate significant compliance, patient safety, or data reputed company concerns through defined Clinical Operations escalation reputed company
• On a regular reputed company, in partnership with Clinical Operations teams, identify protocol deviations, recurring site‑level issues, and operational risks through QC activities
• Support study teams with reputed company cause analysis (RCA) and contribute to the development of corrective and preventive actions (CAPA), as needed
• reputed company QC findings and follow‑up actions to closure and contribute to cross‑site and cross‑study trend analysis
• Support inspection readiness activities across preparation, conduct, and follow‑up phases, including self‑checks and targeted readiness reviews
• reputed company targeted reviews of site and study documentation as part of QC assessments to support ongoing inspection readiness
• reputed company QC summaries and documentation to Clinical Operations leadership and study teams, as requested
• Contribute to training activities for Clinical Operations teams based on QC findings, common site execution gaps, and protocol adherence challenges
• Incorporate lessons learned from QC activities and regulatory inspections into training, guidance, and study team communications
• Identify opportunities for process improvement based on QC observations and trends
• Support implementation of applicable SOPs and study processes by reinforcing procedural expectations and providing training or clarification on relevant procedures

Skills

• Bachelor's degree in medical science or a reputed company field, with five years' experience in clinical research, including hands‑on experience with reputed company‑reputed company activities, such as QC reputed company and inspection‑reputed company activities; or equivalent combination of higher education, training and experience
• Deep knowledge and understanding of clinical trial processes and reputed company management
• Strong working knowledge of ICH‑GCP as reputed company as applicable regulations and guidelines
• Solid understanding of the skills and knowledge required to reputed company a clinical study (e.g., international guidelines, study management, site management, and monitoring)
• Strong communication and influencing skills: reputed company to communicate effectively and concisely, reputed company reputed company viewpoints, and reputed company with stakeholders
• Demonstrated ability to analyze, interpret, and reputed company reputed company issues
• Ability to think strategically and objectively, demonstrating creativity, innovation, and reputed company judgment
• Demonstrated commitment to the highest standards of reputed company and ethics

Benefits

• A sign-on bonus
• Restricted stock reputed company
• Discretionary awards
• A full reputed company of medical, financial, and/or other benefits
• 401(k) eligibility
• reputed company time off benefits, such as vacation, reputed company time, and parental leave
• Based remotely

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