Global Clinical Study Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Responsible for the global delivery of studies within established timelines and budgets while ensuring quality meets inspection readiness standards.

• Oversee all dimensions of assigned clinical studies.

• Direct global cross-functional study teams, including management of external partners, and serve as the escalation point for study-related issues.

• Ensure alignment of study objectives with clinical operations and corporate goals.

• Manage external vendors and collaborate with regional subject matter experts.

• Provide consistent study progress updates to senior management.

• Represent the study team in internal meetings and lead Clinical Study Team discussions.

• Guide planning and management from feasibility through to study closure.

• Develop, manage, maintain, and communicate study timelines.

• Supervise trial feasibility, allocation, and site selection across different regions.

• Ensure timely access to study documents for regulatory and ethics submissions.

• Oversee study start-up and site activation strategies.

• Ensure that study plans, systems, and tools are developed, implemented, and maintained effectively.

• Execute risk-based quality management processes and centralized monitoring analyses.

• Design and implement study-specific training programs and maintain training records.

• Create, maintain, and conduct quality checks on the Trial Master File.

• Anticipate study drug needs and coordinate the timely supply delivery to sites.

• Support data cleaning timelines in collaboration with Data Management and other stakeholders.

• Plan and execute the Clinical Study Report with Medical Writing and study team members.

• Monitor compliance with protocols, SOPs, study plans, ICH/GCP, and applicable regulations.

• Review and manage quality-related metrics to maintain inspection readiness.

• Identify study challenges and ensure that corrective and preventive actions are enacted.

• Communicate risks and challenges to senior management while implementing mitigation strategies.

• Prepare the team for quality assurance audits and inspections.

• Share insights, learnings, and best practices across teams and sites.

• Lead process enhancements and contribute to work instructions and SOPs.

• Select and manage study vendors and approve invoice payments.

• Oversee study budgets, change control, closure budgets, accruals, and forecasts.

• Identify resource needs for the study team and monitor resource utilization.

• Ensure studies are conducted within agreed quality, time, and cost parameters.

⛳️ Requirements

• Demonstrated project management experience in global clinical studies.

• Experience in oncology is preferred.

• Advanced understanding of clinical operations methodologies.

• Comprehensive knowledge of all aspects of clinical study processes.

• Capability to lead global clinical studies independently.

• A minimum of 6 years of progressive experience in clinical research within the biotech, pharma, or CRO sectors.

• Proficiency in MS Office.

• Proficient in project planning applications.

• Familiarity with Clinical Trial Management Systems.

• A Bachelor's Degree in a scientific or healthcare field is required; a higher degree is preferred.

• Travel may be necessary based on business requirements.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Eligibility for discretionary equity awards.

• Participation in a Voluntary Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) plan.

• Flexible Spending Account/Health Savings Account options.

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Reasonable accommodations provided in the job application process.