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 established timelines and budgets while ensuring the highest quality of inspection readiness.

• Oversee all facets of designated clinical studies.

• Direct global cross-functional study teams, including the management of external partners.

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

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

• Contribute to the creation of global tools and standards; lead the development of work instructions and standard operating procedures (SOPs).

• Guide global cross-functional study teams and manage external vendor relationships.

• Collaborate with regional subject matter experts and key organizational stakeholders.

• Provide frequent updates on study progress to senior management.

• Oversee the planning and management of clinical studies from feasibility to closeout.

• Manage timelines, feasibility, trial allocation, site selection, startup, site activation, study plans, systems, training, TMF, data cleaning, supplies, and Clinical Study Reports.

• Monitor adherence to protocols, SOPs, study plans, ICH/GCP guidelines, and relevant regulations.

• Manage quality metrics, inspection readiness, audits, inspections, issues, CAPAs, risks, and mitigation strategies.

• Select and oversee study vendors and authorize invoice payments.

• Handle study budgets, accruals, forecasts, and resource requirements.

• Mentor junior team members.

⛳️ Requirements

• Demonstrated experience in Project Management within Global Clinical Studies (Oncology experience is preferred).

• Extensive knowledge of clinical operations methodologies.

• Comprehensive understanding of all elements of clinical study processes.

• Capable of independently leading global clinical studies.

• A minimum of 7 years of progressive experience in clinical research within the biotech, pharma, or CRO sectors.

• Proficiency in MS Office, Project Planning Applications, and Clinical Trial Management Systems.

• Bachelor's Degree in a scientific or healthcare discipline is required.

• Travel may be necessary based on business needs.

🏝️ Benefits

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

• Qualification for an incentive compensation plan for commercial roles.

• Availability of discretionary equity awards.

• Participation in the Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance benefits.

• 401(k) retirement plan.

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

• Life insurance options.

• Paid Time Off (PTO).

• Access to a wellness program.