"Alerted.org

General Description:

The Associate Director, Digital Clinical Operations Solutions Lead is responsible to formulate and implement GCO digital strategies with the goal to increase Global Clinical Operations’ productivity and reduce clinical trial inefficiencies. Specifically:

+ Identify and define Clinical digital strategies focused on a process or function, which emphasize productivity and high data quality standards to support GCO’s vision of being a world-class clinical operations organization. Opportunity space includes, but is not limited to Clinical Operations analytics, study budgeting, site contracting, site payments, SUSAR distribution, RBQM, Study & Site Feasibility, etc.

+ Engage and align clinical stakeholders across geographies and functions, to create a clear voice of the clinical teams for the purpose of digital solutioning.

+ Mobilize cross-functional clinical teams, internal IT teams and vendors to implement Clinical solutions, inclusive of organizational, process, data and technology components.

+ Maintain and enhance existing clinical systems used by the GCO teams in Planning, Start-up, Managing and Closing clinical trials, and ensure data are accurate, complete, and contemporaneous.

+ Coordinate with the Development & IT teams to identify, select, configure and implement vendor products

+ Coordinate 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

+ Define, track and share business outcome value measures for digital investments

The incumbent will work directly with other members of the GCO, Development and IT organizations and 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_

+ Forge relationships 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

+ Drive 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.

+ Implement the 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

+ Project Management: Drive forward progress, overseeing the management of timelines, resources and vendor accountabilities, as well as project risks and cost.

+ 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

+ Develop solution 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 address these challenges, leveraging existing and innovative approaches.

+ Lead user acceptance testing (UAT), including creation of test plan and test scripts (with assistance from IT or Development functions, as appropriate).

+ Take accountability for business value realization of technology solutions. Ensure that appropriate change tactics are planned and effectively delivered (communications, training, user communities, adoption drives) for both internal and external users. May directly involve development and delivery of these tactics.

+ Focus on user expectation and satisfaction and decreasing user burden. Proactively ensure system usability and user needs remain a high priority.

_Compliance and Continuous Improvements:_

+ Collaborate on 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 with future possibility of managing team members

+ 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 Power BI, Tableau, or similar

+ **Data modeling** is a plus: profiling, regression analysis, forecast models, and other ‘light’ data science skills.

+ **Big Data Technologies** : Familiarity with big data platforms such as Hadoop, Spark, and cloud services Azure Databricks / Synapse

Qualifications:

+ Bachelor’s or Master’s degree Computer Science or related degree

+ 8+ 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. Knowledge of clinical operations systems and associated reporting and visualization tools used in Clinical Operations; utilize past experiences and knowledge to work in an ambitious and fast-paced global biotech company

+ **Stakeholder management** : Ability to work collaboratively with functional leadership and external partners, to forge partnerships and collaborations arrangements.

+ **Cross-functional oversight:** Ability to assemble cross-functional clinical teams to understand their business needs and deliver outcome-aligned solutions. Partner with internal BeiGene 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.

+ **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.

**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.