Opportunity Details

On Assignment LCoE (Learning Centre of Excellence) Curricula & Compliance Manager- CST(Clinical Study Team) Training

Remote East Coast USA

In this role, you will lead 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.

We're looking for professionals with:

• Strong ComplianceWire (or similar LMS) administration experience
• Solid understanding of GxP training requirements in clinical trials
• Proficiency with Veeva Quality Docs/eTMF and advanced Excel/SharePoint skills
• 3+ years in clinical trial training in pharma, biotech, or medical devices (7+ years customer-facing experience strongly preferred)

Fully remote opportunity with occasional travel (up to 10%).

If you have a passion for clinical training compliance and want to make a direct impact on study team readiness, we'd love to hear from you!

Summary:

Under the leadership and direction of the Director, LCoE Curricula & Compliance, the Manager LCoE C3 - CST Training, will work with stakeholders in Clinical Trial Management (CTM) and SMEs across the R&D organization to understand Clinical Study Team (CST) Training compliance business needs and propose system solutions that comply with GxP requirements in a global context.

The LCoE Curricula & Compliance Manager - CST Training, is responsible for deploying and managing training through the Compliance Wire® learning management system (LMS). The individual in this role will leverage a variety of tools to analyze training compliance trends, derive insights, and enhance curricula and role based assignments in support of GxP compliance.

Key Responsibilities

Strategic Alignment:
Responsible for supporting the build out and ongoing maintenance of LMS data structures to support GxP Clinical Study Team Training, ensuring the training system remains audit & inspection ready.

Relationship Management
Partner with LCoE team members to support compliance improvement at global & local levels. Liaise with Clinical Trial Management team including Clinical Study Leads, Program Operations Leads, Clinical Study Specialists to provide guidance on Clinical Study Team Training curricula needs.

Consulting
Skillfully apply systems knowledge and tools, to analyze complex LMS and TMF data issues and propose optimized solutions. Provide guidance to internal customer groups, ensuring compliance in training requirements and documentation & effectiveness in supporting processes. Support regulatory audits and inspections by preparing training reports and retrieving key training records & documents. Navigate GxP source document and team management vaults to ensure alignment of training assets & assignments and work with CTM Team members to ensure timely, accurate & comprehensive assignments.

Curricula Support
Collaborate with stakeholders and the wider LCoE team to establish & maintain study role based curricula and usergroup assignments. Support activities to review & enhance curricula compliance, using system reports to inform curricula & usergroup modifications.

Creativity, Innovation & Problem Solving
Participate in cross-functional continuous improvement projects related to quality & compliance to ensure learner's needs are met with appropriate training through streamlined training operations and overall user support efficiency. Support LCoE leadership in the implementation plan for improving compliance across supported stakeholder groups globally.

Measurement & Reporting
Track trends and monitor training compliance.

Training Delivery
Occasionally prepare presentations & supplementary content to educate or inform stakeholders. Support LCoE leadership in the implementation plan for improving compliance across supported stakeholder groups globally.

JOB REQUIREMENTS:

• Ability to work both independently and collaboratively as part of a remote team.
• High level of Learning Management System (ComplianceWire preferable) administration proficiency in conjunction with navigating source document management systems such as Veeva Quality Docs and/or eTMF (a distinct advantage).
• Detail orientated in document preparation and data entry tasks, with a strong understanding of the significance of data discrepancies. When discrepancies are identified, able to troubleshoot & apply an appropriate GxP compliant solution.
• Knowledge of GxP regulations pertaining to training & quality management systems.
• High level of proficiency in working with MS Tools, especially Excel and SharePoint. The ability to use integrated AI tools (e.g., Microsoft 365 Copilot) is a plus.
• Critical thinking & problem solving are required. Having exposure to and training in lean six sigma or similar methodology is an advantage.
• Experience in managing multiple projects concurrently, with an ability to set and negotiate priorities to meet target dates.
• Clear communication skills, both in person and in writing.
• Experience working with global training teams is preferred.
• May require up to 10% travel.

Qualifications - Education & Experience

• 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, ideally with an agency or group providing services to the pharmaceutical/medical device industry.