Director, Digital Clinical Operations Study Head

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The Director of Digital Clinical Operations Study Head is a member of the Digital GCO Leadership Team, responsible for leading a team, setting and implementing the GCO technology strategy with the goal to increase Global Clinical Operations’ Study related productivity, reduce rising costs of clinical trials, and reduce clinical trial inefficiencies. This will be achieved by:

• Owning and implementing Study specific strategies, processes and systems that emphasize productivity and high data quality standards, to support GCO’s vision of being a world-class clinical operation organization. Study specific processes include, but are not limited to Study Planning, Study Setup & Startup, Study Management including Protocol Amendments, Protocol Deviations, ICF Mgmt., Milestones Mgmt., Risks & Issue Mgmt. etc.
• Maintaining and enhancing existing clinical systems used by the GCO teams in Planning, Start-up, Managing and Closing clinical trials, and ensuring data are accurate, complete, and contemporaneous.
• Identifying, developing, and implementing innovative computerized systems strategies, business case, respective processes, change management including training and user adoption that support the Study specific planning and conduct of agile, high-quality, and efficient clinical operations. Experience with AI/ML solution implementation in Clinical Operations will be a plus
• Working with the Development & IT teams to identify, select, configure and implement vendor products
• Working with the Development & IT teams to collate user stories for functional requirements, participate in sprint planning, sprint testing, SDLC testing including UAT
• Focusing on technological solutions that will improve clinical trial experience of GCO users, quality, and speed of data collection. This may include, and is not limited CTMS, Study Startup, Study Feasibility Clinical Operations reporting & dashboards

The incumbent will work directly with other members of the GCO, Development and IT organizations and be accountable to create policies and procedures where needed, introducing, and implementing novel technology solutions, processes and Roles & Responsibilities.

Essential Functions of the job:  

Leadership and Vision

• Analyze technology and industry trends to identify specific opportunities that ensure BeiGene clinical trials and operations are conducted with fit-for-purpose, cost-effective and innovative computerized systems that are cohesive, efficient, reliable, and compliant with all applicable regulatory expectations
• Create the Study specific GCO technology strategy and roadmap and manage its implementation …