Associate Director, Digital Clinical Operations Solutions Lead

BeiGene, Ltd.; United States; On-site; USD 133,000 - 179,000; Full time

Job summary

A global oncology company seeks a Senior Manager for Digital Clinical Operations Solutions Analytics. This role involves driving digital strategies to enhance clinical trial inefficiencies and operational efficiency, collaborating with various teams, and ensuring compliance. With a focus on patients and excellence, the ideal candidate will possess strong technical skills and a strategic mindset.

Benefits

Comprehensive benefits

Equitable pay practices

Qualifications

• 7+ years of experience in drug development, clinical trial data management, and analytics.
• Expertise in systems, tools, data, analytics, and visualization related to clinical operations.
• Experience with process modeling and core clinical systems.

Responsibilities

• Support the deployment of Clinical Solutions strategies and systems.
• Analyze industry trends for innovative system adoption.
• Develop and maintain Data Governance policies to ensure regulatory compliance.

Skills

Problem-solving

Collaboration

Communication

Education

Bachelor’s degree in Computer Science or related field

Master’s degree preferred

Tools

Tableau

Power BI

Hadoop

Spark

Azure

Job description

Senior Manager, Digital Clinical Operations - Solutions Analytics

Overview

BeOne is experiencing rapid growth and offers challenging opportunities for experienced professionals. We seek scientific and business professionals who are motivated, collaborative, and passionate about fighting cancer.

Role Summary

The Senior Manager, Digital Clinical Operations Solutions Analyst, is responsible for implementing the GCO digital strategy to enhance productivity and reduce clinical trial inefficiencies. Key responsibilities include:

• Supporting the deployment of Clinical Solutions strategies, processes, and systems such as CTMS, Site Payments, RBQM, SUSAR reporting, Clinical Operations dashboards, and Study & Site Feasibility.
• Maintaining and improving existing clinical systems used across various trial phases, ensuring data accuracy and completeness.
• Collaborating with Development & IT teams to select, configure, and implement vendor products.
• Drafting, refining, and finalizing user stories for functional requirements, and participating in SDLC activities including UAT.

Key Responsibilities

Operational Efficiency and Productivity

• Understanding user requirements and identifying automation opportunities to streamline workflows.
• Analyzing industry trends to adopt innovative, cost-effective, and compliant systems.
• Managing the implementation of the GCO digital roadmap to improve operational efficiency and reduce costs.
• Monitoring system performance, troubleshooting issues, and optimizing solutions.
• Promoting a culture of agility, compliance, and data-driven decision-making.
• Partnering with internal departments to develop standards, policies, and procedures for system lifecycle management.
• Supporting CTMS requirements development and stakeholder alignment.
• Identifying manual workflows and developing technological solutions to address challenges.
• Coordinating UAT, creating test plans and scripts, and ensuring effective training for system users.

Compliance and Continuous Improvement

• Developing and maintaining Data Governance policies, SOPs, and system processes to ensure regulatory compliance (e.g., 21 CFR Part 11, ICH E6 R2).
• Leading continuous improvement initiatives and supporting vendor qualification and audit activities.

Supervisory Role

Acting as an individual contributor with mentorship responsibilities as needed.

Technical Skills & Qualifications

• Bachelor’s degree in Computer Science or related field; Master’s preferred.
• 7+ years of experience in drug development, clinical trial data management, and analytics.
• Expertise in systems, tools, data, analytics, and visualization related to clinical operations.
• Strong communication, problem-solving, and collaboration skills.
• Experience with process modeling, core clinical systems, data visualization tools (Tableau, Power BI), and big data platforms (Hadoop, Spark, Azure).

Additional Information

Travel as needed. The role emphasizes our core values: Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit. Compensation ranges from $133,800 to $178,800 annually, with comprehensive benefits and equitable pay practices.

About BeOne

BeOne is a global oncology company committed to developing affordable, accessible cancer treatments. With over 11,000 employees worldwide, we strive to improve access to medicines globally. For more information, visit www.beigene.com and follow us on social media.