Senior Global Clinical Study Manager

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

📋 Description

• Take ownership of global study delivery within established timelines, budget, quality, and inspection-readiness standards for Clinical SuperHighway partnership studies.

• Oversee all phases of assigned clinical studies from feasibility assessments to closeout procedures.

• Lead global, cross-functional study teams while managing external partners and vendors.

• Serve as an escalation point for study-related challenges and keep senior management updated on progress, risks, and issues.

• Strategically plan and manage study timelines, feasibility evaluations, site selection, startup, site activation, submissions, and closeout activities.

• Ensure the development, maintenance, quality control, and proper implementation of study plans, systems, tools, training, and Trial Master Files.

• Apply risk-based quality management processes and oversee study compliance with protocols, standard operating procedures (SOPs), ICH/GCP, and regulatory requirements.

• Prepare teams for quality assurance audits and inspections, maintaining continuous inspection readiness.

• Coordinate forecasting and delivery of supplies, data cleaning schedules, and Clinical Study Report planning.

• Manage study vendors, budgets, invoices, accruals, forecasts, and resource requirements.

• Contribute to process enhancements and develop or refine work instructions and SOPs.

⛳️ Requirements

• Demonstrated project management experience in global clinical studies.

• Oncology experience is preferred.

• Advanced understanding of clinical operations methodologies.

• Comprehensive knowledge of all components of clinical study processes.

• Capability to independently lead global clinical studies.

• A minimum of 8 years of progressive clinical research experience in the biotech, pharmaceutical, or CRO sectors.

• A Bachelor's degree in a scientific or healthcare-related field is required; exceptions may be considered for candidates with relevant clinical operations experience.

• A higher degree is preferred.

• Proficient in MS Office, project planning applications, and Clinical Trial Management Systems (CTMS).

🏝️ Benefits

• Eligibility for an annual bonus plan for Non-Commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

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

• Life insurance coverage.

• Paid Time Off.

• Wellness program.