Global Clinical Study Manager

New

JobgetherClinical research

Remote work opportunity within the United States.Full-TimeManager

SalaryAnnual base salary range of $118,600–$158,600

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Job Details

Experience: At least 6 years of progressive clinical research experience within the biotechnology, pharmaceutical, or CRO industry.
Required Skills: Project ManagementMicrosoft Office

Hold a bachelor’s degree in a scientific or healthcare-related discipline; an advanced degree is preferred. Exceptions may be considered for candidates with substantial relevant clinical operations experience.
Have at least 6 years of progressive clinical research experience in the biotechnology, pharmaceutical, or CRO industry.
Have project management experience leading global clinical studies; oncology experience is preferred.
Demonstrate the ability to independently lead complex global clinical studies across multiple regions and functions.
Have advanced knowledge of clinical operations methodologies and clinical study processes.
Have experience managing study timelines, budgets, vendors, resources, quality requirements, and operational risks.
Have knowledge of ICH/GCP standards, clinical research regulations, study documentation, and inspection-readiness requirements.
Be proficient with Microsoft Office, project planning applications, and clinical trial management systems.
Have strong analytical and data-analysis capabilities.
Have strong communication, stakeholder-management, leadership, and collaboration skills.
Have financial awareness and experience managing clinical study budgets and resources.
Be willing to travel as required by business needs.

Lead assigned global clinical studies from feasibility and planning through execution, closeout, and completion of the Clinical Study Report.
Lead global cross-functional Clinical Study Teams, facilitate decision-making, and act as the primary escalation point for study issues.
Coordinate external vendors and regional subject matter experts involved in study delivery.
Develop and communicate study timelines, monitor milestones, and manage study budgets, forecasts, resources, and contingency plans.
Oversee study start-up, site activation, study plans, essential documentation, and clinical trial systems throughout the study lifecycle.
Implement risk-based quality management, monitor quality metrics, and ensure corrective and preventive actions are implemented.
Maintain Trial Master Files and ensure continuous inspection readiness for audits and regulatory inspections.
Coordinate study documentation and Clinical Study Reports with relevant functional teams, including Medical Writing and Data Management.
Monitor compliance with protocols, SOPs, study plans, ICH/GCP requirements, and applicable regulations.
Drive study efficiency and quality improvements and contribute to clinical operations procedures, work instructions, and SOPs.

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