Associate Director, GCOE Learning and Development
BeOne Medicines
**General Description:**
The Associate Director (AD), GCOE Learning and Development responsible for managing the governance, configuration, and optimization of the Learning Management System (SumTotal or equivalent) for Global Clinical Operations (GCO). This role ensures the delivery and tracking of all GCO-related training, including both functional process-based and clinical study-specific training, for internal employees and external partners such as investigational sites.
The role is accountable for maintaining training compliance across the clinical operations organization. This includes ensuring that curricula align with role requirements, training records meet inspection readiness standards, and study-specific training is executed consistently and effectively.
**Essential Functions of the job:**
**LMS Ownership and Operations**
+ Serve as the business owner and subject matter expert for SumTotal LMS (or equivalent) within GCO.
+ Oversee day-to-day system operations, including training assignments, role mapping, access provisioning, system configuration, and reporting.
+ Develop and maintain governance standards for LMS use, including naming conventions, versioning, assignment logic, and archival processes.
+ Lead system enhancement projects and coordinate with IT, L&D Systems, and vendors to resolve issues or support upgrades.
**Compliance-Driven Curriculum Management**
+ Manage the complete lifecycle of GCO role-based curricula in accordance with GxP requirements.
+ Ensure curricula accurately reflect current SOPs, work instructions, regulatory guidance, and process changes.
+ Monitor training completion and escalate noncompliance to functional leaders and QA as needed.
+ Support audit and inspection readiness by ensuring all training documentation and audit trails are accurate and available.
**Study-Specific Training Governance**
+ Implement and maintain governance for study-specific training within the LMS for both internal staff and external collaborators.
+ Ensure consistency in study training processes, including curriculum creation, learner assignment, version tracking, and documentation.
+ Partner with Clinical Study Teams, Clinical Systems, and Vendor Oversight to ensure appropriate training coverage and tracking for all study team members.
**Data, Metrics, and Reporting**
+ Provide training dashboards, metrics, and compliance reports to leadership, QA, and regulatory stakeholders.
+ Track training key performance indicators and analyze trends to identify areas for improvement.
+ Maintain validated reporting processes and ensure inspection readiness at all times.
**Governance and Process Optimization**
+ Develop and manage SOPs, policies, and governance models related to LMS training operations across GCO.
+ Ensure training data integrity and compliance with system and regulatory standards.
+ Collaborate with Learning Business Partners to support alignment between system-level processes and training needs across functions and regions.
+ Contribute to organizational change initiatives related to training systems and user support.
**Supervisory Responsibilities:**
+ Manage team in accordance with organization’s policies and applicable regulations
+ Direct internal staffing and performance management including hiring, training, coaching, and performance reviews
+ Drive team members to improve their efficiency and effectiveness at prioritizing work and improving performance.
+ Ensure prioritization of activities and resourcing is in line with clinical development programs.
+ Drives for operational excellence
+ Foster a collaborative highly integrated culture
+ Maintain a positive, results orientated, collaborative highly integrated culture
**Computer Skills:**
+ Efficient in Microsoft Word, Excel, Project, PowerPoint, and Outlook.
+ Experience with learning management systems (LMS) and e-learning authoring tools.
**Qualifications:**
+ Bachelor's degree in life sciences, healthcare, education, or related field
+ Minimum 8 years of experience in clinical operations within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
+ Experience in training, process improvement, management of learning management systems (e.g., SumTotal, ComplianceWire Etc.) and/or project management required.
+ Proven track record in managing training governance processes within global, matrixed environments.
+ Experience in end-to-end clinical trial processes including experience in one or more key functions (e.g., Clinical Operations, Clinical Compliance, Clinical Monitoring, Clinical Trial Management, and/or Clinical Quality Assurance.)
+ Experience training on CTMS, TMF systems, or study planning platforms.
+ Process improvement experience using digital tools or automation within LMS environments.
+ Thorough understanding of ICH-GCP regulations.
+ Demonstrated expertise in instructional design, adult learning principles, and training program development.
+ Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements.
**Travel:**
+ Travel required for business purposes
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.
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