Senior Global Clinical Study Manager

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

📋 Description

• Take ownership of the complete global operational delivery for one or more clinical studies, from the initiation stage through to the close-out phase.

• Coordinate cross-functional stakeholders to execute the global study strategy in alignment with timelines, quality standards, and budget constraints.

• Lead global clinical operations teams and act as the primary escalation point for regional issues.

• Ensure that global deliverables are in sync with study objectives.

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

• Provide hands-on leadership, oversight, proactive risk management, and decision-making for global study teams.

• Direct study execution, which includes strategy for start-up, enrollment acceleration, site activation, data flow management, and query resolution.

• Offer oversight and guidance to regional clinical study managers.

• Facilitate coordination among Clinical Operations, Medical, Regulatory, Biometrics, Supply, and other relevant functions.

• Plan and manage studies from feasibility assessments through to closeout.

• Oversee study start-up and recruitment timelines while tracking progress.

• Drive trial feasibility, country allocation, and site selection processes.

• Ensure the timely preparation and submission of study documents to regulatory authorities and Ethics Committees/Institutional Review Boards (ECs/IRBs).

• Maintain precise study systems and tools.

• Collaborate with Clinical Research Associates (CRAs), reviewing and approving monitoring reports.

• Create, maintain, and ensure quality control of country- and site-level Trial Master Files.

• Provide insights on regional drug inventories, labels, regulatory approvals, and reimbursement for comparators.

• Manage the collection of regional trial data, data entry, and query resolution.

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

• Monitor adherence to protocols, SOPs, ICH/GCP guidelines, and regulatory requirements.

• Ensure readiness for inspections and prepare sites for audits and assessments.

• Manage responses to audits and inspections, sharing insights and best practices.

• Enhance the efficiency and quality of assigned studies.

• Plan, monitor, and forecast global study budgets.

• Allocate resources across regions and oversee regional budgets.

• Manage the balance between cost and performance while overseeing study vendors.

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

• Identify resource needs, develop contingency plans, and optimize resource utilization.

• Represent study leadership in cross-functional reviews.

• Communicate the status of studies, associated risks, trade-offs, and plans for mitigation.

• Mentor junior team members and assist in their onboarding process.

⛳️ Requirements

• A minimum of 5 years of project management experience in clinical trials within the biotech, pharmaceutical sector, CRO industry, or a related field.

• Demonstrated expertise in clinical research, including relevant experience as a team lead in clinical functions.

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

• A higher degree is preferred.

• Proficient in MS Office.

• Familiarity with project planning applications.

• Willingness to travel as required by business needs.

🏝️ Benefits

• Annual bonus plan for non-commercial roles.

• 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/Health Savings Account (FSA/HSA).

• Life Insurance coverage.

• Paid Time Off.

• Wellness programs.