Senior Global Clinical Study Manager

BeiGene

3d•$136,400 - $181,400

About The Position

BeOne is seeking a Senior Global Clinical Study Manager to deliver clinical studies within partnership programs under its Clinical Superhighway. The Clinical Superhighway combines internal, end-to-end global development capabilities and is being made available to promising external biotech partners to support high-quality clinical development and broaden access to innovative oncology medicines. The role supports seamless onboarding and execution of partner projects in close collaboration with execution functions. The manager is accountable for global study delivery within agreed timelines and budgets and to appropriate inspection-readiness standards. The role leads all aspects of assigned studies, directs global cross-functional study teams and external partners, and serves as an escalation point for study issues. It also aligns study goals with clinical operations and corporate objectives and contributes to global tools, standards, work instructions, and SOPs. This position leads study planning and execution from feasibility through closeout, including timelines, feasibility and site selection, startup, study plans and systems, risk-based quality management, training, Trial Master File oversight, clinical supplies coordination, data cleaning, and Clinical Study Report planning. It monitors compliance, quality, risks, inspection readiness, budgets, vendor activity, and study resources, while driving improvements and communicating progress and issues to stakeholders and senior management. This is a CST-level role with no people-management responsibilities. Travel is up to 20%, domestically and internationally.

Requirements

At least 8 years of progressive clinical research experience in the biotech, pharmaceutical, or CRO industry.
Proven project management experience in global clinical studies.
Ability to independently lead global clinical studies.
Advanced knowledge of clinical operations methodologies and in-depth understanding of clinical study processes.
Bachelor’s degree in a scientific or healthcare discipline; exceptions may be made for candidates with relevant clinical operations experience.
MS Office skills.
Experience with project planning applications.
Experience with Clinical Trial Management Systems (CTMS).
Ability to travel domestically and internationally, up to 20%.

Nice To Haves

Oncology experience preferred.
A higher degree is preferred.

Responsibilities

Lead the global cross-functional study team, promote effective decision-making, and escalate and resolve study-related issues.
Manage 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 contribute to Clinical Operations process-improvement initiatives.
Plan and manage assigned clinical studies from feasibility through closeout.
Generate, maintain, manage, and communicate study timelines and track progress.
Work with the Global Clinical Program Lead to ensure operational feasibility, and oversee trial feasibility, allocation, and site selection across regions.
Ensure high-quality study documents are available on time for regulatory authority and EC/IRB submissions.
Oversee study startup and site activation plans.
Ensure study plans—including project management, monitoring, Trial Master File, and data monitoring plans—are timely, current, distributed, and implemented.
Ensure study systems and tools are set up correctly and on time, function properly, and contain current 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 delivered, and training records are documented and filed.
Create, maintain, and regularly quality-check the study Trial Master File according to the TMF QC plan.
Coordinate with Global Clinical Supplies to forecast study drug needs and deliver supplies to sites on time.
Support and, when 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 study team to identify and assess issues and ensure corrective and preventive actions are implemented.
Inform senior management and stakeholders of risks and challenges and establish and implement mitigation plans.
Prepare the team for quality assurance audits and inspections; share cross-team and site learnings and best practices.
Lead improvements to increase the efficiency and quality of assigned study work, and develop, optimize, and review work instructions and SOPs as required.
Work with Sourcing to select and manage vendors and approve study invoice payments.
Manage study budgets, including baseline evaluation, change control, closure budgets, and presentations to senior management.
Follow clinical study budgeting processes and provide Finance with 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 studies are delivered within endorsed timelines, quality standards, and cost parameters.