Associate Director, Global Clinical Study Management

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

📋 Description

• Responsible for the global delivery of studies within established timelines, budget constraints, and ensuring inspection-readiness quality.

• Oversee all facets of assigned global clinical studies.

• Lead cross-functional study teams globally and manage external partnerships.

• Serve as the escalation point for issues related to studies.

• Align the objectives of studies with both clinical operations and corporate goals.

• Create global tools, standards, work instructions, and Standard Operating Procedures (SOPs).

• Mentor and coach junior team members and partners.

• Plan and manage clinical studies from the feasibility stage through to closeout.

• Direct trial feasibility, allocation, and site selection across various regions.

• Oversee study timelines, plans, systems, training, and activities related to the Trial Master File.

• Implement processes for risk-based quality management.

• Coordinate clinical supplies, data cleaning, and the execution of Clinical Study Reports.

• Ensure compliance with protocols, SOPs, ICH/GCP, and relevant regulations.

• Manage quality risks, corrective, and preventative actions, as well as audits and readiness for inspections.

• Select and manage vendors, including the approval of invoice payments.

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

• Guarantee that studies are executed within the approved time, quality, and cost parameters.

⛳️ Requirements

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

• Advanced understanding of clinical operations methodologies.

• Comprehensive knowledge of all elements of clinical study processes.

• Capability to independently lead global clinical studies.

• 8 or more years of progressive experience in clinical research within the biotech, pharmaceutical, or CRO industries.

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

• A Bachelor’s Degree in a scientific or healthcare-related field is required.

• Willingness to travel as required by business needs.

🏝️ Benefits

• Eligibility for annual bonus plans 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 benefits.