Associate Director, Digital Clinical Operations

beigene; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

BeOne is seeking an Associate Director, Digital Clinical Operations to optimize the Global Clinical Operations footprint. You will lead CTMS enhancements and digital solution delivery, driving efficiency from study startup through closeout.

You will translate stakeholder needs into prioritized, testable requirements and work with IT to deliver robust solutions. You will collaborate with clinical teams across regions, champion process standardization, and help shape near-term and long-term

Qualifications

• Experience with CTMS and digital solutions used in clinical operations.
• Ability to elicit clear requirements from stakeholders and translate into user stories.
• Strong stakeholder engagement across geographies and functions.
• Familiarity with SDLC, sprint planning, and UAT processes.

Responsibilities

• Detail enhancements for CTMS and digital solutions to improve trial efficiency.
• Collaborate with clinical stakeholders to voice requirements and align with priorities.
• Define business requirements and coordinate with Development/IT to finalize user stories.
• Support roadmaps for current and future CTMS solutions and measure outcomes.

Skills

CTMS

Stakeholder mgmt

SDLC

Agile

Tools

SharePoint

Job description

General Description

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.

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) and other digital solutions. This role will specifically focus on following activities:

• Detail enhancements for existing CTMS and other digital solutions 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 enhancements.
• 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 and other digital applications are 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 and other digital solutions 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 BeOne 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 Ch