General Description:
The Associate Director ,Digital Clinical Operations is responsible to enhance Global Clinical Operations' productivity and reduce clinical trial inefficiencies, by detailing the business critical capabilities from Clinical Study Startup to Study Close Out with focus on use of Clinical Trial Management System (CTMS) application. This role will specifically focus on following activities:
Detail enhancements for existing CTMS system used by the GCO teams in Planning, Start-up, Managing and Closing clinical trials, and ensure data are fit for intended decision-making.
Engage with clinical stakeholders across geographies and functions, to create a clear voice of the clinical teams for the purpose of the delivery of CTMS enhancements.
Elicit clear requirements from stakeholders, ensuring organizational alignment, regional alignment, and process alignment (process standardization, optimization & automation)
Facilitate the prioritization of demand, managing competing interests with objective assessment of value. Ensure that priorities are aligned to organizational priorities. Create transparency into priorities with clear communication to stakeholders. Translate priorities into plans in collaboration with the development team. Manage expectations with stakeholders (leadership and requestors).
Draft & finalize business requirements for prioritized enahncements
Coordinate with the Development & IT teams to refine and finalize user stories for functional requirements, participate in sprint planning, sprint testing, SDLC testing including UAT
Ensure that the CTMS application is aligned to GCO processes. As part of requirement gathering, ensure that related business processes are well defined and probe into process optimization or process solutions where appropriate, to complement digital solutioning. In cases where process is not defined, create process flows aligned with proper functions and leadership.
Support the strategic evolution of the CTMS application with near-term and long-term roadmaps.
Define and articulate the value proposition of all requests, in both quantifiable and qualitative categories.
Define, track and share business outcome value measures for digital investments
Represent GCO business interests as a key member of the implementation team.
Review proposed designs to ensure that solutions are architected to meet the actual need and expected value.
Curate the backlog of demand, ensuring that the user stories and priorities are up-to-date.
Manage the network of champions, fostering two way communication between end-users and the product team.
Setup and maintain a website (sharepoint) for communication with end-users and champions.
Bring innovative approaches and technology from industry emerging trends and past experience.
The incumbent will work directly with GCO clinical stakeholders, Development and IT organizations and support implementing novel technology solutions, processes, and roles & responsibilities.
Essential Functions of the job:
General expectations of a Digital Clinical Operations employee
Forge relationships with users to understand their requirements and processes, identify automation opportunities, collaborate with development/vendor team to create the necessary fit-for-purpose solutions.
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 solutions 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: ensure forward progress, timelines are managed, accountabilities are clear, and project risks and costs are managed.
Promote a culture that exemplifies agility, compliance, process-orientation, data-driven decision-making, and thoughtful use of technology and innovation
Partner with internal BeiGene departments, including Development Data Science, QA and IT, to support the development of documentation 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.
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.
Education Required:
Bachelor's or Master's degree Computer Science or related degree
8+ years' experience in drug development clinical trial operations
Supervisory Responsibilities:
Be an individual contributor
Oversee consultants or analysts on a matrixed team (as needed)
Technical Skills:
Requirement gathering and documentation
Process modeling
Familiarity with clinical applications e.g. CTMS, EDC, IRT
Soft skills:
Stakeholder management : Ability to work collaboratively with functional leadership and external partners, to forge partnerships and collaborations arrangements. Ability to manage expectations, to communicate to broad groups of end-users.
Communication : Exhibits strong cross-cultural awareness, and strong verbal and written communication skills to effectively convey complex insights to non-technical stakeholders
Cross-functional oversight: Ability to collaborate with 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.
Problem-Solving : Excellent conceptual, analytical, and problem-solving skills to identify trends and make data-driven decisions. Troubleshooting skills.
Able to drive forward progress
Required experience:
Clinical Operations domain expertise
Business analysis on technology projects
Core clinical systems
SDLC
Validated systems
Familiarity with data processing / engineering is a plus
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.
