Senior Learning Business Partner, Global Clinical Operations

Role Summary

Senior Learning Business Partner, Global Clinical Operations. Lead implementation of the GCOE learning and development strategy for GCO new hires across roles in clinical operations. Act as regional point of contact for global learning and development, identify global learning needs, and develop onboarding, role-based, and process-driven training. Mentor junior Learning & Development team members.

Responsibilities

• Act as a liaison between the GCO L&D and regional stakeholders to ensure learning is aligned to business needs and meets regional needs.
• Collaborate with regional cross-functional teams within Clinical Operations to identify training needs and priorities.
• Lead the creation and/or maintenance of GCO Onboarding training.
• Design training materials, presentations, e-learning modules, and other educational resources tailored to different roles and levels within clinical operations.
• Maintain and track learning material within the learning management system including version control, retirement of material, and cataloging content.
• Review training materials from GCO business partners and make recommendations to improve methods.
• Support review of SOPs and training documentation resulting from new processes or process improvements and rolls out GCO training and/or lessons learned, as appropriate.
• Identify gaps in GCO process and develop a learning solution to meet business needs.
• Apply innovative design thinking and adult learning principles in the design of learning experiences across regions.
• Engage and manage external vendors to develop/deliver content, as needed.
• Generate and lead Train-the-Trainer for facilitators.
• Create and manage Learning brand strategy for respective programs, including development of branding materials and learning collateral.
• Anticipate needs to create a modern, digital learning experience that enables development and long-term career growth.
• Stay up to date with latest and future learning experience trends and share best practices.

Process Improvement

• Make learning recommendations for change management strategy activities.
• Serve as subject matter expert on strategic initiatives.
• Support in development and/or maintenance of global forms, templates, guidance documents, and or reference tools.

Manage Metrics

• Manage and track training attendance and performance for GCO organization. This may be in onboarding or for new hire.
• Evaluate the effectiveness of training programs on a regional level through participant feedback, performance metrics, and assessments.
• Engage regional functional business partners to respond to process metrics and trending data to identify gaps.
• Present role-based proficiency metrics to regional stakeholders.
• Assist with identification of opportunities for content enhancement based on industry trends, process changes, and inspection results.
• Gather feedback on learning experiences, preferred vendor experience / evaluation, and facilitator experience for continuous improvement.
• Propose learning process changes based on feedback.

Education/Experience

• Bachelor’s degree in life sciences with minimum of 7 years of experience in pharmaceutical or biotechnology across clinical trial operations. Minimum 2 years of experience in clinical trial monitoring or direct study management.
• Minimum 2 years of experience in training, process improvement, and/or project management.
• Experience in clinical operations as clinical research associate, clinical study manager, or compliance.

Computer Skills

• Understanding of learning management systems and training development software.
• Understanding of clinical operations software such as EDC, CTMS, and eTMF.

Other Qualifications

• Experience in end-to-end clinical trial processes including Clinical Operations, Clinical Compliance, Clinical Monitoring, CTM, and/or Clinical Quality Assurance.
• Thorough understanding of ICH-GCP regulations.
• Strong communication and presentation skills with the ability to convey complex information to diverse audiences.
• Understanding of industry regulations, compliance, and validated systems.
• Project management skills (PMP not required).
• Proven ability to facilitate meetings and training sessions.

Travel

Minimal as needed for meetings