Senior 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 specified timelines, budgets, and ensuring inspection-readiness quality.

• Oversee all elements of assigned clinical studies.

• Lead global cross-functional study teams and manage external partners.

• Serve as the escalation point for resolving study-related issues.

• Align study objectives with clinical operations and corporate goals.

• Create global tools, standards, work instructions, and SOPs.

• Assist in the onboarding process and ensure high-quality execution of projects with external partners.

• Oversee vendor management and work collaboratively with regional subject matter experts.

• Provide updates on study progress to senior management.

• Direct study planning and management from feasibility through to closeout.

• Oversee study timelines, feasibility assessments, site selection, startup, activation, and overall study plans.

• Ensure all regulatory and ethics committee submission documents are prepared and available.

• Implement risk-based quality management processes and maintain study systems.

• Develop training specific to the study and maintain related training records.

• Create, maintain, and ensure quality control of the Trial Master File.

• Anticipate study drug supplies and coordinate their delivery to sites.

• Support timelines for data cleaning and planning of Clinical Study Reports.

• Monitor compliance with protocols, SOPs, ICH/GCP guidelines, study plans, and regulatory requirements.

• Manage quality metrics, readiness for inspection, audits, inspections, risks, and corrective/preventive actions.

• Select and oversee vendors while approving invoice payments.

• Manage study budgets, forecasts, accruals, resources, and contingency plans.

• Engage in process-improvement initiatives and share best practices.

⛳️ Requirements

• Bachelor’s degree in a scientific or healthcare discipline is required, although exceptions may apply for candidates with relevant clinical operations experience.

• At least 8 years of progressive experience in clinical research within the biotech, pharma, or CRO sectors.

• Demonstrated project management experience in global clinical studies.

• Advanced understanding of clinical operations methodologies.

• Comprehensive knowledge of all components of clinical study processes.

• Capability to independently lead global clinical studies.

• Proficiency in MS Office.

• Familiarity with project planning applications.

• Proficiency in Clinical Trial Management Systems (CTMS).

• Willingness to travel domestically and internationally, up to 20% of the time.

• Experience in oncology is preferred.

• A higher degree is preferred.

🏝️ Benefits

• Eligibility for annual bonus plans for non-commercial roles.

• Participation in incentive compensation plans for commercial roles.

• Access to discretionary equity awards.

• Opportunity to participate in a Voluntary Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA)/Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Reasonable accommodations for individuals with disabilities.