Manager, Study Operations - Training and Development

START Center for Cancer Research

23d • $90,000 - $120,000 • Remote

About The Position

The Study Operations Manager - Training and Development is responsible for leading onboarding, training, competency development, and operational readiness programs for Study Operations personnel across the START network. This role leverages deep expertise in clinical research operations to develop, deliver, and continuously improve structured training programs for Clinical Research Coordinators (CRCs), Study Operations leaders, and other site-based research staff, with a primary focus on supporting newly activated and expanding START sites. Serving as a Study Operations subject matter expert, this individual partners closely with Site Leadership, Shared Services, Clinical Education, Quality, Regulatory, Nursing, Pharmacy, and other functional teams to ensure new employees receive role-specific onboarding, competency-based training, coaching, and ongoing support. The Manager will facilitate onboarding experiences, coordinate training delivered by subject matter experts, oversee shadowing programs, assess learner readiness, and support new sites through launch and early growth phases. Upon successful achievement of onboarding and readiness milestones, this role will partner with other Clinical Education team members to transition employees and sites into ongoing development and ramp-up programs. Success in this role will be measured by onboarding effectiveness, employee readiness, competency achievement, operational consistency, compliance adherence, site launch success, and overall support of START's growth strategy.

Requirements

• 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.
• Ability to facilitate both virtual and in-person training sessions.

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.

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
• Commitment to a supportive environment that values balance, wellbeing, and flexibility

What This Job Offers

• Job Type: Full-time
• Career Level: Manager