Training and Change Management Consultant – eClinical Systems
Location: West Coast, USA
Job Type: Full-time
Position Summary:
We are seeking a highly motivated and experienced Training and Change Management Consultant to support successful adoption of eClinical technologies, including CTMS, eTMF, EDC, RTSM, and Safety & Pharmacovigilance platforms.
The ideal candidate will have a strong background in clinical operations and digital systems implementation, with demonstrated expertise in training strategy, user enablement, stakeholder engagement, and organizational change management.
This role plays a pivotal part in empowering clinical trial teams, sites, sponsors, and CROs to confidently adopt and utilize advanced eClinical platforms through tailored training programs and change management frameworks.
Key Responsibilities
- Design and deliver engaging, role-based training programs (live, virtual, on-demand) across eClinical systems including CTMS, eTMF, EDC, RTSM, and Safety.
- Develop learning assets such as SOP-based guides, eLearning modules, quick reference guides (QRGs), job aids, and FAQs.
- Customize training content based on clinical workflows, user personas (e.g., CRAs, study managers, pharmacovigilance officers), and system configurations.
- Conduct “Train-the-Trainer” sessions for internal teams, client stakeholders, and site partners.
Change Management
- Define and execute change management strategies to ensure user readiness, reduce resistance, and accelerate adoption.
- Identify organizational impacts and develop mitigation plans, communication strategies, and stakeholder engagement initiatives.
- Facilitate readiness assessments, stakeholder alignment sessions, and change agent enablement.
- Track user feedback and adoption metrics to inform change reinforcement actions.
- Collaborate with product managers, business analysts, clinical operations, and IT teams to align training content with real-world use cases and system features.
- Provide subject matter expertise during client onboarding, UAT sessions, and go-live support.
- Serve as a trusted advisor to clinical teams, offering guidance on best practices in system usage and compliance.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Education, Organizational Change, or a related field.
- 7+ years of experience in clinical research, clinical systems training, or organizational change management.
- Demonstrated expertise in one or more eClinical systems: CTMS, eTMF, EDC, RTSM, Safety/Pharmacovigilance platforms.
- Proven experience in developing and delivering training to diverse clinical roles (sites, CROs, sponsors).
- Familiarity with Salesforce-based or cloud-based eClinical solutions is a strong plus.
- Strong knowledge of GCP, 21 CFR Part 11, and regulatory compliance in clinical trials.
- Excellent presentation, communication, and stakeholder management skills.
- Change management certification (e.g., Prosci) or training delivery certification (e.g., ATD, CPTD) is preferred.
- Experience in global and multicultural environments is a plus.
Why Join Us
- Drive digital transformation in life sciences and clinical research
- Make a measurable impact on clinical trial efficiency and user experience
- Work with leading-edge eClinical platforms and cross-functional teams
- Flexible, collaborative, and mission-driven work environment
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