Senior Manager, Digital Clinical Operations - Solutions Analytics

BeiGene; United States; Remote; USD 133,000 - 179,000; Full time

Job summary

A leading biotechnology company is seeking a Senior Manager for Digital Clinical Operations Solutions. This role focuses on improving operational efficiency in clinical trials through innovative technology and data analytics. Candidates should possess significant experience in drug development and the ability to effectively bridge communication between technical and non-technical stakeholders.

Benefits

Comprehensive benefits package including Medical, Dental, Vision, 401(k)

Employee Stock Purchase Plan

Wellness initiatives and Paid Time Off

Qualifications

• 7+ years’ experience in drug development, managing clinical trial data.
• Domain expertise in systems, tools, data, analytics related to clinical operations.
• Strong verbal and written communication skills.

Responsibilities

• Implement the GCO digital strategy to enhance productivity.
• Support analysis of technology trends to improve clinical trials.
• Manage the implementation of GCO technology roadmap.

Skills

Analytical Thinking/Data Analysis

Problem-Solving

Collaboration

Communication

Education

Bachelor’s degree in Computer Science or related degree

Masters degree preferred

Tools

Tableau

Power BI

Hadoop

Spark

Azure Databricks

Azure Synapse

Job description

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne 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 Senior Manager, Digital Clinical Operations Solutions Analyst is responsible to implement the GCO digital strategy with the goal to increase Global Clinical Operations’ productivity and reduce clinical trial inefficiencies. This will be achieved by:

• Supporting the implementation of Clinical Solutions 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. Clinical Solutions include, but are not limited to CTMS, Site Payments, RBQM, , SUSAR reporting, Clinical Operations reporting / dashboards, Study & Site Feasibility 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.
• Working with the Development & IT teams to identify, select, configure and implement vendor products
• Working with the Development & IT teams to draft, refine and finalize user stories for functional requirements, participate in sprint planning, sprint testing, SDLC testing including UAT

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

Essential Functions of the job:

Operational Efficiency and Productivity

• Work with users to understand their requirements and processes, identify automation opportunities, collaborate with vendors to create the necessary fit-for-purpose solution throughout their respective lifecycles
• Support the analysis of the technology and industry trends to identify specific opportunities that ensure BeOne 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.
• Manage the implementation of GCO technology roadmap to increase Global Clinical Operations’ productivity, reduce rising costs of clinical trials, and reduce clinical trial inefficiencies
• Monitor, evaluate, and optimize the performance and quality of the technology solutions, as well as troubleshoot and resolve any issues that may arise
• Promote a culture that exemplifies agility, compliance, process-orientation, data-driven decision-making, and thoughtful use of technology and innovation
• Partner with internal BeOne departments, including Development Data Science, QA and IT, to support the development of standards, policies, and procedures associated with computerized systems, including lifecycle management for existing systems, and the implementation of innovative new systems
• Support the development of clinical trial management system (CTMS) requirements and standards in alignment with stakeholders (Clinical Operations, Data Management, Supply Chain, etc.)
• Identify pain points and manual workflows, and develop technological solutions that will improve these challenges
• Support the Digital Clinical Operations team and coordinate user acceptance testing (UAT), manage creation of test plan and test scripts. (with assistance from IT or Development functions, as appropriate)
• Ensure development of clinical trial tools & systems training materials and delivering effective training to internal and external system users
• Focus on user expectation and satisfaction and decreasing user burden. Proactively ensure system usability remains a high priority, and/or ensure users have the appropriate support structure and user community (training, user group etc.)
• Project Management: Support the management of initiatives, ensuring timely delivery while supporting the management of the risk and cost
• Roadmap Implementation: Support the implementation of GCO digital roadmap

Compliance and Continuous Improvements:

• Support the development of Data Governance global policies, Standard Operation Procedures (SOP), other controlled documents, and the end-to-end system processes. Ensure that systems and documentation are compliant with all relevant Regulatory requirements, including 21 CFR Part 11, ICH E6 (R2) as well as in accordance BeOne SOPs and processes. Lead and support continuous improvement of system projects impacting GCO. With support from QA, ensure qualification of vendors, support audit activities, and actively monitor vendor performance trends

Supervisory Responsibilities:

• Be an individual contributor
• Act as mentor to direct reports and their associates (as needed)

Technical Skills:

• Process modeling
• Core clinical systems
• Data Requirements: Gather and document solution requirements from various internal & external sources (datasets and stakeholders)
• Data Visualization : Ability to create clear and insightful visualizations using tools like Tableau, Power BI, or similar
• Big Data Technologies : Familiarity with big data platforms such as Hadoop, Spark, and cloud services Azure Databricks / Synapse

Qualifications:

• Bachelor’s degree in Computer Science or related degree. Masters degree preferred
• 7+ years’ experience in drug development, managing clinical trial data and analytics
• Domain expertise: Breadth of experience in systems, tools, data, analytics and visualizations related to clinical operations to create unique and differentiated clinical operations’ value and business outcomes. utilize past experiences and knowledge to work in an ambitious and fast-paced global biotech company
• Communication : Exhibits an agile mindset, strong cross-cultural awareness, and strong verbal and written communication skills to effectively convey complex insights to non-technical stakeholders
• Problem-Solving : Excellent conceptual, analytical, and problem-solving skills to identify trends and make data-driven decisions.
• Collaboration : Ability to work collaboratively with cross-functional teams to understand their business needs and deliver solutions. Partner with internal BeOne departments, including Development Data Science, QA and IT, to develop standards, policies, and procedures associated with computerized systems, including lifecycle management for existing systems, and the implementation of innovative new systems

Travel: As needed

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $133,800.00 - $178,800.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene, Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.