Manager, Study Operations – Training and Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Design, implement, and consistently enhance standardized onboarding and training initiatives for Study Operations staff throughout the START network.

• Develop and uphold role-specific training curricula, onboarding pathways, competency frameworks, learning plans, educational materials, job aids, workflows, and training documentation.

• Ensure that training content is in accordance with START SOPs, work instructions, GCP standards, regulatory requirements, and operational best practices.

• Act as the main onboarding lead and training resource for newly recruited Clinical Research Coordinators, Study Operations leaders, and research operations personnel.

• Facilitate instructor-led, virtual, hands-on, site-based, and small-group training sessions.

• Conduct readiness evaluations, identify developmental needs, provide coaching and mentoring, and implement remediation strategies.

• Track onboarding progress and maintain training records, competency documentation, and completion metrics.

• Oversee Study Operations onboarding for newly activated and expanding START sites.

• Create site readiness plans and onboarding strategies in collaboration with Site Development, Site Leadership, and Shared Services teams.

• Organize shadowing experiences at established START sites and offer support to employees before, during, and after their shadowing experiences.

• Assess employee and site readiness and recommend actions to leadership.

• Assist in 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 sessions.

• Provide guidance and support related to Study Operations for employees and leaders.

• Conduct regular competency assessments, monitor compliance, evaluate training effectiveness, and provide updates to leadership.

• Identify opportunities for process improvements, escalate training issues, and recommend corrective actions and development plans.

⛳️ Requirements

• Bachelor’s degree in health administration, Nursing, Life Sciences, or a related field.

• Knowledge of GCP, ICH guidelines, FDA regulations, and clinical research operations.

• Previous experience as a Clinical Research Coordinator, Lead CRC, Study Operations Manager, or a similar clinical research leadership position.

• Proven experience in onboarding, training, mentoring, or developing clinical research professionals.

• Experience in facilitating training programs and delivering adult learning in healthcare or clinical research settings.

• Proficiency in Microsoft Office applications, CTMS platforms, EHR systems, and clinical research documentation systems.

• Excellent presentation, facilitation, coaching, communication, and organizational abilities.

• Must have a dedicated in-home office space.

• Willingness to travel up to 50%.

• Capability to conduct both virtual and in-person training sessions.

🏝️ Benefits

• 401(k) retirement savings plan with employer matching.

• Eligibility for an annual performance bonus, contingent upon role and company results.

• Generous paid time off and paid holidays.

• Comprehensive medical, dental, and vision coverage along with optional insurance options.

• Company-paid life and disability insurance.

• Employee Assistance Program (EAP) offering confidential, no-cost support for you and your family from day one.

• Flexible FSA and HSA plans.

• Supportive work environment that prioritizes balance, wellbeing, and flexibility.

• Opportunities for continuous learning and professional development.

• A collaborative, creative, and inclusive workplace.