Manager, Study Operations – Training and Development
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Job Description
Training and development manager preparing clinical research staff for cancer trial site launches. Building onboarding, competency, and operational-readiness programs for START’s oncology research network.
Responsibilities:
- Develop, implement, and continuously improve standardized onboarding and training programs for Study Operations personnel across the START network
- Create and maintain role-specific training curricula, onboarding pathways, competency frameworks, learning plans, educational resources, job aids, workflows, and training documentation
- Ensure training content aligns with START SOPs, work instructions, GCP requirements, regulatory standards, and operational best practices
- Serve as the primary onboarding lead and training resource for newly hired Clinical Research Coordinators, Study Operations leaders, and research operations personnel
- Deliver instructor-led, virtual, hands-on, site-based, and small-group training sessions
- Conduct readiness assessments, identify development needs, provide coaching and mentoring, and implement remediation plans
- Monitor onboarding progress and maintain training records, competency documentation, and completion metrics
- Lead Study Operations onboarding for newly activated and expanding START sites
- Develop site readiness plans and onboarding strategies with Site Development, Site Leadership, and Shared Services teams
- Coordinate shadowing experiences at established START sites and support employees before, during, and after shadowing
- Evaluate employee and site readiness and recommend actions to leadership
- Support site ramp-up and transition ongoing development needs to operational leadership and Clinical Education colleagues
- Collaborate with cross-functional subject matter experts to coordinate and deliver training
- Provide Study Operations guidance and support to employees and leaders
- Conduct recurring competency assessments, monitor compliance, track training effectiveness, and provide updates to leadership
- Identify process improvements, escalate training concerns, and recommend corrective actions and development plans
Requirements:
- Bachelor’s degree in health administration, Nursing, Life Sciences, or other related field
- Knowledge of GCP, ICH guidelines, FDA regulations, and clinical research operations
- Prior experience as a Clinical Research Coordinator, Lead CRC, Study Operations Manager, or equivalent clinical research leadership role
- Demonstrated experience onboarding, training, mentoring, or developing clinical research professionals
- Experience facilitating training programs and delivering adult learning in healthcare or clinical research environments
- Proficiency in Microsoft Office applications, CTMS platforms, EHR systems, and clinical research documentation systems
- Strong presentation, facilitation, coaching, communication, and organizational skills
- Must have dedicated in-home office space
- 50% travel is required
- Ability to facilitate both virtual and in-person training sessions
Benefits:
- 401(k) retirement savings plan with employer match
- Eligibility for an annual performance bonus, based on role and company results
- Generous paid time off and paid holidays
- Comprehensive medical, dental, and vision coverage and optional insurance options
- Company paid life and disability insurance
- Employee Assistance Program (EAP) providing confidential, no-cost support for you and your family from day one
- Flexible FSA and HSA plans
- Supportive environment that values balance, wellbeing, and flexibility
- Continuous learning and professional growth
- Collaborative, creative, inclusive workplace
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