BeOne Medicines
Director, Digital Clinical Operations Solutions
BeOne Medicines, San Mateo, California, United States, 94409
General Description:
The Director of Digital Clinical Operations Solutions is a member of the Digital GCO Leadership Team, responsible for leading a team to implement the GCO digital 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 Clinical Solutions strategies, processes and systems that emphasize productivity and high data quality standards, to support GCO's vision of being a world-class clinical operation organization. Clinical Solutions include, but are not limited to CTMS, Site Payments, RBQM, IRT, Clinical Supplies, SUSAR reporting, Clinical Operations reporting / dashboards, Study & Site Feasibility etc.
Maintaining and enhancing existing clinical systems used by the GCO teams in Planning, Start-up, Managing and Closing clinical trials, and ensuring data are accurate, complete, and contemporaneous.
Working with the Development & IT teams to identify, select, configure and implement vendor products
Working with the Development & IT teams to collate user stories for functional requirements, participate in sprint planning, sprint testing, SDLC testing including UAT
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 solutions, processes, and Roles & Responsibilities.
Essential Functions of the job:
Leadership and Vision
Analyze technology and industry trends to identify specific 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.
Manage the implementation of GCO technology roadmap 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 solution 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 standards, policies, and procedures associated with computerized systems, including lifecycle management for existing systems, and the implementation of innovative new systems
Plan, monitor and adjust Digital Clinical Operations workforce, to meet dynamic needs of GCO teams
Operational Efficiency and Productivity
Provide operational expertise and implement new and upgrade the 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 digital clinical solutions
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
Act as highest escalation point for clinical trial systems for critical issues and ensure vendors provides timely and accurate resolution
Support the Digital Clinical Operations team and coordinate user acceptance testing (UAT), manage creation of test plan and 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. Proactively ensure system usability remains a high priority, and/or ensure users have the appropriate support structure and user community (training, user group etc.)
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
Participate in 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
Supervisory Responsibilities:
Build & Lead global Digital Study Clinical Operations team of digital business analyst(s) / Implementation & Support analyst(s) / Training analyst(s) / Integration analyst(s)
Provide functional and administrative managerial responsibilities to global reports
Act as mentor to direct reports and their associates
Technical Skills:
Breadth of experience in clinical operations' & clinical system implementation strategy, roadmaps & delivery, transformation of systems and their respective processes, and new technology solutions to create unique and differentiated clinical operations' value and business outcomes for Study Specific digital solutions
Deep knowledge of clinical operations 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
Education Required:
Bachelor's or Master's degree Computer Science, Business Administration, Operations Management
10+ years' experience in drug development, managing clinical trial systems or relevant concentration
5+ years in leadership roles as leader in multicultural & international (global) environment a plus
Other Qualifications:
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
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 Operations
Exhibits an agile mindset, strong cross-cultural awareness, and excellent communication skills
Travel:
As needed
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.
The Director of Digital Clinical Operations Solutions is a member of the Digital GCO Leadership Team, responsible for leading a team to implement the GCO digital 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 Clinical Solutions strategies, processes and systems that emphasize productivity and high data quality standards, to support GCO's vision of being a world-class clinical operation organization. Clinical Solutions include, but are not limited to CTMS, Site Payments, RBQM, IRT, Clinical Supplies, SUSAR reporting, Clinical Operations reporting / dashboards, Study & Site Feasibility etc.
Maintaining and enhancing existing clinical systems used by the GCO teams in Planning, Start-up, Managing and Closing clinical trials, and ensuring data are accurate, complete, and contemporaneous.
Working with the Development & IT teams to identify, select, configure and implement vendor products
Working with the Development & IT teams to collate user stories for functional requirements, participate in sprint planning, sprint testing, SDLC testing including UAT
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 solutions, processes, and Roles & Responsibilities.
Essential Functions of the job:
Leadership and Vision
Analyze technology and industry trends to identify specific 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.
Manage the implementation of GCO technology roadmap 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 solution 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 standards, policies, and procedures associated with computerized systems, including lifecycle management for existing systems, and the implementation of innovative new systems
Plan, monitor and adjust Digital Clinical Operations workforce, to meet dynamic needs of GCO teams
Operational Efficiency and Productivity
Provide operational expertise and implement new and upgrade the 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 digital clinical solutions
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
Act as highest escalation point for clinical trial systems for critical issues and ensure vendors provides timely and accurate resolution
Support the Digital Clinical Operations team and coordinate user acceptance testing (UAT), manage creation of test plan and 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. Proactively ensure system usability remains a high priority, and/or ensure users have the appropriate support structure and user community (training, user group etc.)
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
Participate in 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
Supervisory Responsibilities:
Build & Lead global Digital Study Clinical Operations team of digital business analyst(s) / Implementation & Support analyst(s) / Training analyst(s) / Integration analyst(s)
Provide functional and administrative managerial responsibilities to global reports
Act as mentor to direct reports and their associates
Technical Skills:
Breadth of experience in clinical operations' & clinical system implementation strategy, roadmaps & delivery, transformation of systems and their respective processes, and new technology solutions to create unique and differentiated clinical operations' value and business outcomes for Study Specific digital solutions
Deep knowledge of clinical operations 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
Education Required:
Bachelor's or Master's degree Computer Science, Business Administration, Operations Management
10+ years' experience in drug development, managing clinical trial systems or relevant concentration
5+ years in leadership roles as leader in multicultural & international (global) environment a plus
Other Qualifications:
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
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 Operations
Exhibits an agile mindset, strong cross-cultural awareness, and excellent communication skills
Travel:
As needed
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.