OpenClinica LLC

OpenClinica makes clinical trials more efficient and effective with advanced technology and recruitment solutions. Trusted by the world's leading life sciences companies, academic institutions, and government agencies, OpenClinica bridges the gap between healthcare and research.

Director of Training

Learning and DevelopmentLearning and DevelopmentFull TimeRemote

Location

United States

Posted

37 days ago

Salary

Not specified

Clinical ResearchLMSInstructional DesignGx P21 CFR Part 11Saa S TrainingEnterprise Software TrainingAdult Learning TheoryTraining Strategy

Job Description

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

The Director of Training is responsible for the strategy, design, and delivery of high-quality training programs for the OpenClinica Suite of products. This role ensures that customers, partners, and internal teams are fully enabled to use the software effectively, compliantly, and confidently within regulated clinical research environments.

  • Define and execute a global training strategy aligned with product roadmap, customer needs, and business goals
  • Build, lead, and mentor a team of trainers, instructional designers, and training managers
  • Establish training standards, methodologies, and best practices across all delivery formats
  • Design, implement and maintain role-based training curricula for customers, partners, and internal teams
  • Develop deep product expertise across the OpenClinica platform to ensure useful, high quality, efficient training delivery
  • Ensure training content reflects clinical trial workflows, regulatory requirements (e.g., GxP, 21 CFR Part 11), and system updates
  • Partner with Product, Engineering, and Clinical SMEs to translate complex functionality into clear learning materials
  • Lead delivery of instructor-led, virtual, and on-demand training programs
  • Support enterprise customer onboarding and complex implementations with tailored training plans
  • Ensure consistency and quality across global training engagements
  • Collaborate with Customer Success, Professional Services, and Support to drive product adoption and customer satisfaction
  • Monitor training effectiveness and its impact on customer outcomes and retention
  • Act as a senior training escalation point for strategic accounts
  • Own training platforms (LMS), certifications, and learning analytics
  • Define and track KPIs such as training completion, proficiency, satisfaction, and adoption metrics
  • Continuously evaluate and improve training programs based on feedback and data
  • Ensure training programs, materials and delivery methods align with internal quality standards and applicable regulatory expectations
  • Partner with Compliance to support audit and inspection readiness

Qualifications

  • 8+ years of experience in training, enablement, or learning & development, with at least 3 years in a leadership role
  • Experience training enterprise software solutions, preferably SaaS
  • Strong understanding of clinical trial operations and/or life sciences technology
  • Proven ability to design scalable, role-based training programs
  • Excellent communication and stakeholder-management skills
  • Prolonged periods sitting at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times
  • Travel may be required on occasion (<5%)

Requirements

  • Experience with EDC, ePRO/eCOA, Patient Recruiting, Data Analytics, Randomization, CTMS, or other clinical research systems
  • Familiarity with regulatory frameworks such as GxP and 21 CFR Part 11
  • Experience implementing or managing an LMS
  • Background in adult learning theory or instructional design
  • Experience supporting or participating in customer, sponsor, or regulatory audits related to training, system use, or user qualification

Company Description

OpenClinica makes clinical trials more efficient and effective with advanced technology and recruitment solutions. Trusted by the world's leading life sciences companies, academic institutions, and government agencies, OpenClinica bridges the gap between healthcare and research.

Job Requirements

  • 8+ years of experience in training, enablement, or learning & development, with at least 3 years in a leadership role
  • Experience training enterprise software solutions, preferably SaaS
  • Strong understanding of clinical trial operations and/or life sciences technology
  • Proven ability to design scalable, role-based training programs
  • Excellent communication and stakeholder-management skills
  • Prolonged periods sitting at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times
  • Travel may be required on occasion (<5%)
  • Experience with EDC, ePRO/eCOA, Patient Recruiting, Data Analytics, Randomization, CTMS, or other clinical research systems
  • Familiarity with regulatory frameworks such as GxP and 21 CFR Part 11
  • Experience implementing or managing an LMS
  • Background in adult learning theory or instructional design
  • Experience supporting or participating in customer, sponsor, or regulatory audits related to training, system use, or user qualification

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