Global Clinical Study Lead — Cross-Functional

BeiGene, Ltd.; United States Virgin Islands; On-site; USD 136,000 - 181,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. in the United States is seeking aSenior Global Clinical Study Lead to manage delivery of oncology programs, coordinating cross-functional teams, external partners, and regulatory readiness.

The role requires extensive experience in clinical research, a Bachelor's or higher in a scientific field, and the ability to lead end-to-end studies across regions, ensuring inspection readiness and overall Quality/Compliance. Travel may be required; competitive benefits offered.

Qualifications

• Bachelor's Degree in a scientific or healthcare discipline required*
• Higher Degree preferred *exceptions might be made for candidates with relevant clinical operations experience
• Proven Project Management experience in Global Clinical Studies (Oncology experience preferred)
• Advanced knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes
• Able to independently lead global clinical studies
• 7+ or more years of progressive experience in clinical research within biotech, pharma or CRO industry

Responsibilities

• Leads the global cross-functional study team effectively, ensures effective decision making, and acts as point of escalation for resolution of study related issues
• Leads external vendors management involved in study delivery
• Builds trust and relationship with regional subject matter experts and supports the delivery of their local study objectives
• Collaborates with key stakeholders across the organization and provides regular updates on study progress to senior management as required
• Represents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings
• Participates and presents at various topics of Clinical Study Management
• Participates in Clinical Operations Process improvement initiative
• Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities
• Generates, manages, maintains, and communicates high quality study timelines and tracks progress towards these
• Ensures that the clinical studies are operationally feasible along with Global Clinical Program Lead, oversees trial feasibility, trial allocation and site selection process across all regions
• Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs
• Provides oversight to study start up and site activation plans
• Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, …) are created, updated and distributed timely and implemented appropriately
• Ensures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systems
• Implements RBQM end-to-end processes on time within the allocated study (e.g., periodic reviews, centralized monitoring analyses, action items)
• Ensures relevant study specific training is developed and implemented and ensures training records are well documented and filed
• Ensures Trial Master File for study is created, maintained and QC’d on a regular basis as per the study TMF QC plan
• Collaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites
• Supports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders (including but not limited to regional clinical operations teams and medicator monitor)
• Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members

Skills

Project management

Clinical operations

Leadership

Global studies

Education

Bachelor's degree in science

Higher degree preferred

Tools

MS Office

Project planning apps

Clinical Trial Management Systems

Job description

BeOne Medicines Ltd. in the United States is seeking aSenior Global Clinical Study Lead to manage delivery of oncology programs, coordinating cross-functional teams, external partners, and regulatory readiness.

The role requires extensive experience in clinical research, a Bachelor's or higher in a scientific field, and the ability to lead end-to-end studies across regions, ensuring inspection readiness and overall Quality/Compliance. Travel may be required; competitive benefits offered.