Associate Director, Digital Clinical Operations

Role Summary

Associate Director, Digital Clinical Operations

Responsibilities

• 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 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 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.

Education Required

• Bachelor‚Äôs or Master‚Äôs degree Computer Science or related degree
• 8+ years‚Äô 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