Global Clinical Study Manager

BeiGene

4d•$118,600 - $158,600

About The Position

The Global Clinical Study Manager is accountable for delivery of assigned global clinical studies within agreed timelines and budgets, while maintaining appropriate quality and inspection readiness. The role leads all aspects of assigned studies and directs global cross-functional study teams, including oversight of external partners. It serves as an escalation point for study issues and ensures study goals align with clinical operations and corporate objectives. Experience managing global oncology studies is sought, preferably including pivotal studies and health authority inspection management. The role leads study planning and execution from feasibility through closeout, including timelines, feasibility and site selection, start-up, study documentation and plans, study systems, risk-based quality management, training, Trial Master File oversight, clinical supplies coordination, data cleaning, and Clinical Study Report planning and execution. It ensures compliance with protocols, SOPs, ICH/GCP, and applicable regulations, maintains inspection readiness, manages risks and quality measures, and supports audits and inspections. The manager also works with sourcing and finance on vendor selection, invoices, budgets, accruals, and forecasts; monitors study resources and utilization; and helps ensure delivery within endorsed time, quality, and cost parameters. The role provides performance feedback on team members as required. Travel may be required based on business need.

Requirements

Bachelor’s degree in a scientific or healthcare discipline; exceptions may be made for candidates with relevant clinical operations experience.
Proven project management experience in global clinical studies.
Ability to independently lead global clinical studies; pivotal study management experience is required.
At least 5 years of progressive clinical research experience within the biotech, pharmaceutical, or CRO industry.
Advanced knowledge of clinical operations methodologies and in-depth understanding of clinical study processes.
Computer skills with MS Office, project planning applications, and clinical trial management systems.

Nice To Haves

A higher degree is preferred.
Oncology experience is preferred.
Experience managing global oncology studies, preferably pivotal studies and health authority inspection management.

Responsibilities

Lead the global cross-functional study team, support effective decision-making, and resolve or escalate study-related issues.
Oversee external vendors involved in study delivery.
Build relationships with regional subject matter experts and support delivery of local study objectives.
Collaborate with organizational stakeholders and provide study progress updates to senior management as required.
Represent the study team at internal meetings and lead Clinical Study Team meetings.
Participate in and present on Clinical Study Management topics, and participate in Clinical Operations process improvement initiatives.
Plan and manage assigned clinical studies from feasibility through closeout.
Generate, maintain, communicate, and track high-quality study timelines.
Oversee trial feasibility, allocation, and site selection across regions with the Global Clinical Program Lead.
Ensure high-quality study documents are available in time for regulatory authority and EC/IRB submissions.
Oversee study start-up and site activation plans.
Ensure study plans are created, updated, distributed, and implemented appropriately.
Ensure study systems and tools are set up correctly and on time, function properly, and contain up-to-date study information.
Implement end-to-end risk-based quality management processes, including periodic reviews, centralized monitoring analyses, and action items.
Ensure study-specific training is developed and implemented and training records are documented and filed.
Ensure the study Trial Master File is created, maintained, and regularly quality-checked according to the TMF QC plan.
Coordinate with Global Clinical Supplies to forecast study drug and ensure timely delivery of supplies to sites.
Support and, as needed, drive data-cleaning timelines with Data Management and other stakeholders.
Plan and execute the Clinical Study Report with Medical Writing and relevant Clinical Study Team members.
Monitor study activities for compliance with the protocol, SOPs, study plans, ICH/GCP, and other applicable regulations.
Review and manage quality-related GCO metrics within acceptable limits and maintain inspection readiness throughout the study lifecycle.
Work with the cross-functional study team to identify and evaluate study issues and implement corrective and preventive actions.
Inform senior management and key stakeholders of risks and challenges and ensure risk mitigation plans are implemented.
Prepare the team for quality assurance audits and inspections.
Share cross-team and site learnings and best practices with Clinical Study Team members and colleagues.
Lead improvements that enhance the efficiency and quality of work on assigned studies; contribute to developing, optimizing, and reviewing work instructions and SOPs as required.
Work with sourcing to select and manage study vendors and approve invoice payments throughout the study.
Manage study budgets, including baseline evaluation, change control, closure budgets, and presentations to senior management.
Follow clinical study budgeting processes and provide finance with budget accrual and forecast input.
Identify and manage study team resource needs, establish contingency plans for key resources, and monitor resource utilization over the study lifecycle.
Ensure clinical studies are executed within endorsed time, quality, and cost parameters.
Provide performance feedback on team members as required.