Associate Director, Digital Clinical Operations
2 weeks ago
Associate Director, Digital Clinical Operations Join to apply for the Associate Director, Digital Clinical Operations role at BeOne Medicines 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. General Description The Associate Director, Digital Clinical Operations is responsible for enhancing Global Clinical Operations’ productivity and reducing clinical trial inefficiencies by detailing the business-critical capabilities from Clinical Study Startup to Study Close Out with a focus on the use of the Clinical Trial Management System (CTMS) application. This role will specifically focus on the following activities: Detail enhancements for the 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 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, and 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 solutions where appropriate. In cases where a 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. Set up 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 Forge relationships with users to understand their requirements and processes, identify automation opportunities, collaborate with development/vendor team to create fit-for-purpose solutions. Drive the analysis of 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 & Experience Required Bachelor’s or Master’s degree in Computer Science or related field. 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, forge partnerships and collaboration arrangements, manage expectations, 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. Global Competencies Fosters Teamwork. Provides and Solicits Honest and Actionable Feedback. Self-Awareness. Acts Inclusively. Demonstrates Initiative. Entrepreneurial Mindset. Continuous Learning. Embraces Change. Results-Oriented. Analytical Thinking/Data Analysis. Financial Excellence. Communicates with Clarity. Salary Range $140,500.00 - $190,500.00 annually 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. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact Seniority level Director Employment type Full‑time Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at BeOne Medicines by 2x. #J-18808-Ljbffr
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Associate Director, Digital Clinical Operations
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, , Canada BeOne Medicines Full timeAssociate Director, Digital Clinical Operations 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....
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