Training Curricula & Compliance Manager
kps life · Pennsylvania, United States · 1 wk ago
RemoteRemoteAnalystFull-time
About the Role
KPS Life is hiring a remote LCoE (Learning Centre of Excellence) Curricula & Compliance Manager to be fully dedicated to one of our sponsor partners. In this role, you will lead Clinical Study Team (CST) training strategy and compliance through the ComplianceWire LMS, partnering closely with Clinical Trial Management and cross-functional R&D stakeholders. You'll design and maintain role-based curricula, ensure GxP audit readiness, analyze training data for insights, and support regulatory inspections while driving continuous improvement across a global organization.
Responsibilities
- Strategic Alignment: Support the build-out and ongoing maintenance of LMS data structures to ensure GxP Clinical Study Team Training compliance, keeping the training system audit- and inspection-ready.
- Relationship Management: Partner with the LCoE team to support compliance improvement at global and local levels. Liaise with Clinical Trial Management, including Clinical Study Leads, Program Operations Leads, and Clinical Study Specialists, to provide guidance on CST training curricula needs.
- Consulting: Apply systems knowledge and tools to analyze complex LMS and TMF data issues, proposing optimized solutions. Provide compliance guidance to internal customer groups on training requirements, documentation, and process effectiveness. Support regulatory audits and inspections by preparing training reports and retrieving key records.
- Curricula Support: Collaborate with stakeholders and the LCoE team to establish and maintain study role-based curricula and user group assignments. Review and enhance curricula compliance using system reports to inform modifications.
- Creativity, Innovation & Problem Solving: Participate in cross-functional continuous improvement projects to ensure learner needs are met through streamlined training operations. Support LCoE leadership in implementing plans to improve compliance across global stakeholder groups.
- Measurement & Reporting: Track trends and monitor training compliance. Occasionally prepare presentations and supplementary content to educate or inform stakeholders.
Requirements
- Ability to work both independently and collaboratively as part of a remote team.
- High proficiency in Learning Management System (ComplianceWire preferred) administration, along with experience navigating source document management systems such as Veeva Quality Docs and/or eTMF.
- Detail-oriented in document preparation and data entry, with a strong understanding of data discrepancies and the ability to troubleshoot and apply GxP-compliant solutions.
- Knowledge of GxP regulations pertaining to training and quality management systems.
- High proficiency in MS Tools, especially Excel and SharePoint; experience with integrated AI tools (e.g., Microsoft 365 Copilot) is a plus.
- Critical thinking and problem-solving skills; exposure to Lean Six Sigma or similar methodologies is an advantage.
- Experience managing multiple projects concurrently, with the ability to set and negotiate priorities to meet deadlines.
- Clear communication skills, both written and verbal.
- Experience working with global training teams is preferred.
- Up to 10% travel may be required.
Qualifications
- Bachelor’s degree required.
- Minimum of 3 years of experience in clinical, pharmaceutical, or medical device industries with an understanding of GxP guidelines as they relate to training.
- Ideally 7+ years of experience in a customer-facing role, preferably with an agency or group providing services to the pharmaceutical or medical device industry.
Schedule
Fully remote opportunity with occasional travel (up to 10%).