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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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.