Senior Global Study Management Associate

BeiGene

23h•$83,800 - $113,800

About The Position

The Senior Global Study Management Associate supports the Global Clinical Study Manager in delivering global clinical studies, ensuring delegated study components meet specified quality standards and are completed within timelines and budget. The role supports alignment of study goals with clinical operations objectives, study vendor management, and other assigned study-management activities. The associate helps coordinate cross-functional study teams and stakeholders; maintains study systems, records, and access; supports study planning, document review, investigator meetings, feasibility assessments, and tracking of key study deliverables. The role also contributes to study communications, Trial Master File quality and maintenance, study drug supply activities, data cleaning, and Clinical Study Report planning and execution. Additional responsibilities include supporting operational risk management, quality and process improvement, vendor selection and setup, and study budget administration, including purchase order setup and invoice tracking. The position may include mentoring junior colleagues or supporting new-hire onboarding. Limited travel may be required.

Requirements

At least 3 years of clinical research experience within the biotech, pharmaceutical, or CRO industry.
Knowledge of clinical operations methodologies and understanding of operational aspects of clinical study processes.
Bachelor’s degree or higher in a scientific or healthcare discipline; exceptions may be made for candidates with relevant clinical operations experience.
Proficiency in the MS Office Suite, including Excel, PowerPoint, and Project.

Nice To Haves

A higher degree in a scientific or healthcare discipline is preferred.
Knowledge of clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines.
Limited travel may be required.

Responsibilities

Support the Global Clinical Study Manager in global study delivery and execution of delegated study components to expected quality standards, timelines, and budget.
Support alignment of study goals with clinical operations goals and objectives.
Support study vendor management and other assigned study-management activities.
Coordinate the organization and logistics of cross-functional Clinical Study Team meetings and collaborate with global and regional stakeholders.
Contribute to task force initiatives and cross-functional projects, including process improvement, standardization, and implementation activities.
Create and maintain study-level SharePoint sites and Clinical Study Team distribution lists.
Set up studies in systems such as eTMF and CTMS, keep study information current, and support appropriate system access and user-account management throughout the study lifecycle.
Support development of study plans and review study-related documents as delegated.
Organize study-specific investigator meetings under the Global Clinical Study Manager’s supervision.
Support creation and review of site feasibility assessments when needed.
Manage and track study deliverables, including screening, enrollment, biological samples and images, data flow, and protocol deviations, in collaboration with Regional Clinical Trial Management Associates.
Prepare management metrics and updates on key deliverables using information available in relevant systems.
Support preparation of study newsletters, FAQs, lessons learned, and other study-conduct correspondence in collaboration with the study team.
Support the TMF specialist with study-level TMF creation and, as required, maintain the TMF and conduct regular document review and quality control according to the study TMF QC plan.
Support study drug forecasts and study drug supply activities in collaboration with Global Clinical Supplies.
Support data-cleaning activities and follow-up on outstanding information.
Support planning and execution of the Clinical Study Report.
Help identify operational risks and issues and work with the Global Clinical Study Manager to recommend solutions for discussion with appropriate team leadership.
Learn and share clinical-operations best practices, emphasizing quality and compliance, and suggest improvements to efficiency and work quality.
May support development of global study tools, work instructions, and SOPs.
Support vendor selection and setup for global outsourced activities.
Support study budget management, including purchase order setup and payment invoice tracking across study lifecycles.
May mentor junior team members or support onboarding of new hires.
Use MS Office Suite, including Excel, PowerPoint, and Project.