Note: The job is a remote job and is open to candidates in USA. The START Center for Cancer Research is a global early-phase oncology clinical research site network dedicated to expanding access to cutting-edge clinical trials. The Study Operations Manager - Training and Development leads onboarding, training, competency development, and operational readiness programs for Study Operations personnel, supporting newly activated and expanding sites across the network.
Responsibilities
- Develop, implement, and continuously improve standardized onboarding and training programs for Study Operations personnel across the START network
- Create, revise, and maintain role-specific training curricula, onboarding pathways, competency frameworks, learning plans, educational resources, job aids, and operational workflows
- Develop and maintain training documentation, study-specific training materials, platform user guides, process maps, and supplemental learning resources
- Ensure all training content aligns with START SOPs, work instructions, GCP requirements, regulatory standards, and operational best practices
- Support the development and implementation of scalable training solutions that support rapid growth and expansion across the organization
- Serve as the primary onboarding lead and training resource for newly hired Clinical Research Coordinators, Study Operations leaders, and other research operations personnel
- Deliver instructor-led, virtual, and hands-on training sessions focused on clinical research operations, systems, workflows, and START standards
- Conduct baseline assessments to evaluate learner readiness, identify development needs, and customize onboarding support
- Provide ongoing one-on-one coaching, mentoring, and performance support throughout onboarding and role transition periods
- Facilitate individual and small-group learning sessions to reinforce operational knowledge, role proficiency, and clinical research best practices
- Identify performance gaps and implement targeted remediation and development plans to accelerate competency achievement
- Monitor onboarding progress and maintain training records, competency documentation, and learner completion metrics
- Lead Study Operations onboarding initiatives for newly activated and expanding START sites
- Partner with Site Development, Site Leadership, and Shared Services teams to develop site readiness plans and onboarding strategies
- Ensure newly hired personnel understand START operational standards, workflows, systems, and compliance expectations
- Coordinate and schedule shadowing experiences at established START sites to support experiential learning and operational consistency
- Provide support before, during, and after shadowing activities to reinforce learning objectives and competency development
- Evaluate employee and site readiness throughout onboarding and provide recommendations to leadership regarding operational preparedness
- Support site ramp-up activities and coordinate transition of ongoing development needs to operational leadership and Clinical Education colleagues once onboarding objectives have been achieved
- Facilitate a seamless handoff from onboarding to long-term training and development programs as sites transition into ramping and growth phases
- Collaborate with Subject Matter Experts (SMEs) across Regulatory, Quality, Nursing, Pharmacy, Site Development, Study Start-Up, Study Operations, and Shared Services teams to coordinate and deliver training programs
- Partners with departments implementing new systems, technologies, or workflows to develop and execute effective training strategies
- Lead site-based, virtual, and small-group training sessions focused on operational workflows, system utilization, study conduct, and compliance requirements
- Serve as a Study Operations subject matter expert and provide operational guidance and support to employees and leaders across the organization
- Evaluate employee competency throughout onboarding and ongoing training to ensure readiness and proficiency in role-specific responsibilities
- Conduct recurring competency assessments and identify knowledge gaps requiring remediation, reinforcement, or additional training
- Deliver compliance-focused training and monitor adherence to SOPs, work instructions, GCP standards, and regulatory requirements
- Track onboarding effectiveness through learner feedback, competency assessments, operational metrics, and performance data
- Provide regular onboarding, readiness, and training effectiveness updates to leadership teams
- Use continuous process improvement methodologies to identify opportunities for improving onboarding, operational readiness, and employee performance
- Escalate training concerns and recommend corrective actions and development plans when appropriate
- Other duties may be assigned at any time
Skills
- Bachelor's degree in health administration, Nursing, Life Sciences, or other related field
- 5+ years of clinical research operations experience, preferably in early phase oncology, with at least three years training, onboarding and mentoring research staff
- 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 to support new site launches, onboarding activities, shadowing experiences, workforce readiness initiatives, and operational training programs
- Ability to facilitate both virtual and in-person training sessions
- Candidates based in EST or CST time zones strongly preferred
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 for added financial protection
- Employee Assistance Program (EAP) providing confidential, no-cost support for you and your family from day one
- Flexible FSA and HSA plans to support your financial wellness
- A supportive environment that values balance, wellbeing, and flexibility
- A collaborative, creative workplace where every team member is encouraged to contribute
- Continuous learning and professional growth opportunities
- An inclusive and innovative workplace culture
Company Overview