Campus Pride Jobs

General Description:

The Executive Director of Digital Clinical Operations is a member of the GCO Leadership Team, responsible for leading a team, setting and implementing the GCO technology strategy with the goal to increase Global Clinical Operations’ productivity, reduce rising costs of clinical trials, and reduce clinical trial inefficiencies. This will be achieved by:

• Owning and implementing strategies, processes and systems that emphasize productivity and high data quality standards, in order to support GCO’s vision of being a world-class clinical operations organization

• Maintaining and enhancing existing clinical systems, and ensuring data are accurate, complete and contemporaneous

• Identifying, developing, and implementing innovative computerized systems strategies and their respective processes that support the planning and conduct of agile, high-quality and efficient clinical operations and clinical trials

• Focusing on technological solutions that will improve clinical trial experience of patients and clinical site staff, quality and speed of data collection as well as monitoring. This may include, and is not limited to, eDiary, eCOA, patient engagement dashboard, patient recruitment, telemedicine, decentralized clinical trials, CTMS, and clinical operations dashboards

The incumbent will work directly with other members of the GCO, Development and IT organizations and be accountable to create policies and procedures where needed, introducing and implementing novel technology infrastructure, and managing GCO technology budget.

Responsibilities:

• Leadership and Vision

• Is a member of the GCO leadership team, and support GCO by leading or contribute extensively to corporate initiatives

• Analyze technology and industry trends to identify opportunities that ensure BeiGene clinical trials and operations are conducted with fit-for-purpose, cost-effective and innovative computerized systems that are cohesive, efficient, reliable, and compliant with all applicable regulatory expectations

• Create the GCO technology strategy and roadmap and manage its implementation end-to-end, to increase Global Clinical Operations’ productivity, reduce rising costs of clinical trials, and reduce clinical trial inefficiencies

• Build and lead a proficient team that will work with users to understand their requirements and processes, identify automation opportunities, collaborate with vendors to create the necessary fit-for-purpose systems, validate the resulting systems, and maintain systems throughout their respective lifecycles

• Monitor, evaluate, and optimize the performance and quality of the technology solutions, as well as troubleshoot and resolve any issues that may arise

• Provide business and technical knowledge, and leadership behavior coaching to Clinical Operations Management Systems & Innovation and cross-functional team members

• 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 develop strategic goals, standards, policies, and procedures associated with computerized systems, including lifecycle management for existing systems, and the exploration, assessment, and implementation of innovative new systems

• Drive development and execution of Clinical Operations Management Systems & Innovation Team staffing strategy and plans

• Plan, monitor and adjust Clinical Operations Management Systems & Innovation Team workforce, to meet dynamic needs of study teams

• Operational Efficiency and Productivity

• Provide operational expertise and identify, target, and secure new technological solutions that will increase productivity and efficiencies of the GCO organization and that of clinical trials

• Identify necessary skills to build within GCO and responsible technologies to implement

• Oversee the development of clinical trial management system 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 will improve these challenges

• Own annual budget planning process and ensure reliable adherence

• Act as highest escalation point on clinical trial systems for critical issues and ensure vendors provides timely and accurate resolution

• Ensure that the Clinical Operations Management Systems & Innovation Team coordinates acceptance testing (UAT), manages creation of test plan, as well as develops test scripts. (with assistance from IT or Development functions, as appropriate)

• Ensure development of clinical trial tools & systems training materials and delivering effective training to internal and external system users

• Focus on user expectation and satisfaction, and decreasing user burden; users will range from patients, clinical site staff, to Clinical Operations and BeiGene associates Proactively ensure system usability remains a high priority, and/or ensure users have the appropriate support structure and user community (training, user groups…)

• Compliance and Continuous Improvements

• Own and drive execution of the clinical trial management systems & innovation end-to-end process continuous improvement roadmap, and engage cross-functional teams with best practices and trend insights

• Own the development of global policies, Standard Operation Procedures (SOP), other controlled documents, and the end-to-end system processes

• Ensure that systems and documentation are compliant with all relevant Regulatory requirements, including 21 CFR Part 11, ICH E6 (R2) as well as in accordance BeiGene SOPs and processes

• Lead and support continuous improvement of system projects impacting GCO

• With support from QA, ensure qualification of vendors, support audit activities, and actively monitor vendor performance trends

• Decentralized Clinical Trials (DCT)

• As the SME, accountable for the development, the oversight, and the execution of the DCT strategy around the world

• Implement DCT at BeiGene in collaboration with impacted and enabling functions across the company

Education Required:

• Master’s degree or PhD in Computer Science, Business Administration, Operations Management

• 10+ years’ experience in drug development, managing clinical trial systems or relevant concentration

• 14+ years of progressive experience in drug development managing clinical trial systems

• 5+ years in leadership roles as leader in multicultural & international (global) environment a plus

Supervisory Responsibilities :

• Lead global Digital Clinical Operations for GCO

• Provide functional and administrative managerial responsibilities to country level direct reports

• Act as mentor to direct reports and their associates

• Be an influential and inspirational leader to the GCO and Development Systems Users Community

Key Experience:

• Breadth of experience in clinical operations’ strategy, clinical system strategy, business case, roadmaps & delivery, transformation of systems and their respective processes, and new technology solutions to create unique and differentiated clinical operations’ value and business outcomes

• Must have good enterprise strategic thinking and analytical skills, with proven ability to translate GCO strategy into actions and goal achievement to serve GCO and Development

• Deep knowledge of clinical management systems and associated reporting and visualization tools used in Clinical Operations

• Proven project management, and/or IT project leadership skills aligning technology initiatives with organizational goals

• Has a diverse background working with Sponsors, CROs, and Clinical sites; utilize past experiences and knowledge to work in an ambitious and fast-paced global company with a focus on optimizing current practices in Clinical Research

• Exhibits an agile mindset, strong cross-cultural awareness, and excellent communication skills

• Conceptual, analytical, and strategic thinking

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.