[Hiring] Senior Manager, Digital Clinical Operations @BeiGene

Role Description

The Senior Manager, 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 the 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.
• 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.
• Work directly with GCO clinical stakeholders, Development and IT organizations and support implementing novel technology solutions, processes, and roles & responsibilities.

Qualifications

• Bachelor’s or master’s degree in computer science or related degree.
• 7+ years’ experience in drug development clinical trial operations.
• Clinical Operations domain expertise.
• Business analysis on technology projects.
• Core clinical systems.
• SDLC.
• Validated systems.
• Familiarity with data processing / engineering is a plus.

Requirements

• Requirement gathering and documentation.
• Process modeling.
• Familiarity with clinical operations applications e.g. CTMS.

Benefits

• Medical, Dental, Vision.
• 401(k), FSA/HSA.
• Life Insurance.
• Paid Time Off.
• Wellness programs.

Company Description

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.