Regional Clinical Study Manager

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

📋 Description

• Responsible for overseeing regional study delivery, ensuring quality that meets inspection readiness, within set timelines and budget constraints.

• Serve as the regional lead for various studies within a specific indication or program.

• Direct regional clinical operations teams and collaborate with external regional partners.

• Act as the primary point of contact for any regional study-related issues.

• Ensure alignment of regional deliverables with the overarching study objectives.

• Create regional tools, work instructions, and standard operating procedures (SOPs).

• Guide the regional planning and management of clinical studies from the feasibility phase to closeout.

• Oversee study initiation and recruitment timelines while tracking progress.

• Facilitate trial feasibility assessments, country allocations, and site selections.

• Coordinate local modifications of global study documents and manage regulatory/ethics submissions.

• Maintain updated regional and country information within study systems.

• Partner with Clinical Research Associates (CRAs) to ensure effective study execution and review monitoring reports.

• Guarantee the creation, maintenance, and quality control of the regional and country-level Trial Master File.

• Provide insights regarding clinical supplies, drug inventories, labels, and the status of comparator drugs.

• Oversee regional data collection, data entry, and resolution of queries.

• Assist in the planning and execution of Clinical Study Reports.

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

• Ensure readiness for inspections and prepare sites for audits.

• Lead initiatives for quality improvements and disseminate best practices.

• Select and manage regional vendors effectively.

• Administer regional study budgets.

• Handle investigator fees, site payments, and reimbursements for patient travel.

• Manage regional resource requirements and their utilization.

• Provide performance feedback and mentor junior team members.

⛳️ Requirements

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

• A higher degree is preferred.

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

• Demonstrated experience in clinical research, particularly as a team lead in clinical functions.

• Experience as a Clinical Research Associate (CRA) is preferred.

• Proficiency in MS Office applications.

• Proficiency in Project Planning Applications.

• Relevant clinical operations experience may allow for exceptions to the educational requirement.

• Travel may be necessary based on business needs.

🏝️ Benefits

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

• Eligibility for an incentive compensation plan for 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.

• Paid Time Off.

• Wellness benefits.

• Reasonable accommodations provided during the application process.