Operations Manager – Clinical Trials Office (CTO)

We are seeking an experienced Operations Manager – Clinical Trials Office (CTO) to oversee oncology clinical trial operations in a leading pediatric healthcare research environment. This role is responsible for managing the full lifecycle of oncology clinical trials, leading research teams, ensuring regulatory compliance, and supporting operational excellence within the Phase I Pediatric Oncology Unit.

Responsibilities

• Lead and supervise Clinical Research Coordinators and research operations staff.
• Oversee clinical trials from study startup through closeout.
• Assess feasibility of new studies and coordinate study activation.
• Ensure compliance with GCP, institutional policies, and regulatory requirements.
• Monitor patient enrollment and recruitment goals.
• Maintain accurate CTMS records and study tracking.
• Collaborate with physicians, investigators, sponsors, and cross-functional teams.
• Develop and improve workflows, SOPs, and operational processes.
• Ensure timely data entry, adverse event reporting, and protocol adherence.
• Mentor, train, and develop research staff.

Qualifications

• Bachelor's Degree or equivalent clinical research experience.
• 4–7 years of clinical research experience in an Academic Medical Center, Hospital, CRO, Pharmaceutical, or Medical Device environment.
• 2–4 years of leadership or management experience overseeing research teams.
• Strong knowledge of Clinical Trial Management Systems (CTMS) and e-Regulatory systems.
• Solid understanding of GCP, clinical trial operations, regulatory compliance, and protocol management.
• Master's Degree preferred.

Preferred Skills

• Oncology clinical research experience.
• Pediatric clinical trial experience preferred.
• Strong leadership, communication, and organizational skills.
• Experience improving research operations and team performance.
• Ability to manage multiple studies in a fast-paced environment.

Benefits

• Competitive hourly compensation.
• Opportunity to lead innovative pediatric oncology clinical research.
• Collaborative and mission-driven healthcare environment.
• Professional growth and leadership development opportunities.