Manager, Study Operations – Training and Development

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

👻 Ghost score 10%

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Logo of The START Center for Cancer Research

The START Center for Cancer Research

501 - 1000 employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

The START Center for Cancer Research is a global clinical research organization focused on early-phase oncology trials and advancing cancer therapies. START operates large, world-class research facilities across the United States and Europe and runs programs (such as the START Hope Hub) to help patients and families find, understand, and enroll in clinical trials. START serves patients, referring physicians, hospitals and oncology practices, and pharmaceutical partners, emphasizing broad access to clinical trials and translational cancer research.

📋 Description

• 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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