Job Overview
Employment Type
Full-time
Compensation
Salary
Range $101,800.00 - $168,900.00
Work Schedule
Standard Hours
Benefits
Health Insurance
Dental Insurance
Paid Time Off
Retirement Plan
Professional development opportunities
Flexible work schedule
Employee assistance program
Job Description
Nicklaus Children's Hospital is a renowned pediatric healthcare facility dedicated to providing compassionate and comprehensive medical care for children. Recognized for its commitment to excellence and innovation, the hospital specializes in a wide range of pediatric specialties including oncology, which focuses on treating children with cancer and related conditions. With a strong emphasis on research and clinical trials, Nicklaus Children's strives to advance pediatric medicine by integrating cutting-edge clinical studies and therapies into patient care to improve outcomes and quality of life for young patients. The hospital fosters a collaborative environment where multidisciplinary teams work together to ensure that each child receives individualized treatment and support throughout their healthcare journey. Nicklaus Children’s Clinical Trials Office plays a critical role in this mission by overseeing the conduct and management of clinical research, ensuring that trials are executed with the highest standards of quality and compliance.
The Operations Manager Clinical Trials Office within the oncology department will hold a pivotal leadership role responsible for independently managing all clinical study operations from activation through close-out. This position primarily focuses on the Phase 1 unit in pediatric oncology but has oversight for all oncology department trials. The manager will be accountable for the frontline supervision of clinical trials staff, guaranteeing efficient workflows, staff alignment with performance standards, and adherence to Good Clinical Practice (GCP). This role requires extensive expertise in clinical research operations and a proven ability to collaborate effectively across cross-functional teams. The ideal candidate will be deeply committed to compliance and ethical conduct in clinical research while driving successful trial execution tailored to pediatric patients' unique needs.
Key responsibilities include managing and mentoring a dynamic team of clinical research coordinators, overseeing study feasibility assessments, and directing the execution of clinical trials. The role supports the broader research mission of Nicklaus Children's Health System by strategically enhancing early phase research programs and ensuring compliance with evolving regulatory requirements. The Operations Manager is also responsible for maintaining accurate clinical trial management systems, monitoring recruitment efforts, collaborating with physicians on training needs, and ensuring high-quality data collection and adverse event reporting. This position acts as a critical liaison with hospital compliance teams to address conflict-of-interest matters and patient health information protection. Through expert guidance, training, and leadership, the Operations Manager helps cultivate a research culture centered on ethical standards and operational excellence. This full-time role offers a challenging and rewarding opportunity for professionals passionate about advancing pediatric oncology research within a supportive and innovative healthcare organization.
The Operations Manager Clinical Trials Office within the oncology department will hold a pivotal leadership role responsible for independently managing all clinical study operations from activation through close-out. This position primarily focuses on the Phase 1 unit in pediatric oncology but has oversight for all oncology department trials. The manager will be accountable for the frontline supervision of clinical trials staff, guaranteeing efficient workflows, staff alignment with performance standards, and adherence to Good Clinical Practice (GCP). This role requires extensive expertise in clinical research operations and a proven ability to collaborate effectively across cross-functional teams. The ideal candidate will be deeply committed to compliance and ethical conduct in clinical research while driving successful trial execution tailored to pediatric patients' unique needs.
Key responsibilities include managing and mentoring a dynamic team of clinical research coordinators, overseeing study feasibility assessments, and directing the execution of clinical trials. The role supports the broader research mission of Nicklaus Children's Health System by strategically enhancing early phase research programs and ensuring compliance with evolving regulatory requirements. The Operations Manager is also responsible for maintaining accurate clinical trial management systems, monitoring recruitment efforts, collaborating with physicians on training needs, and ensuring high-quality data collection and adverse event reporting. This position acts as a critical liaison with hospital compliance teams to address conflict-of-interest matters and patient health information protection. Through expert guidance, training, and leadership, the Operations Manager helps cultivate a research culture centered on ethical standards and operational excellence. This full-time role offers a challenging and rewarding opportunity for professionals passionate about advancing pediatric oncology research within a supportive and innovative healthcare organization.
Job Requirements
- Bachelor's degree or equivalent related research work experience
- 4-7 years of clinical research experience in an academic hospital or similar setting
- 2-4 years of clinical research team leadership experience in a supervisory or managerial role
- Proficiency in clinical trial management systems and regulatory compliance
- Strong communication and analytical skills
- Ability to work under pressure and adapt to changing research regulations
- Demonstrated leadership and mentoring capabilities
- Knowledge of ethical standards and Good Clinical Practice guidelines
Job Qualifications
- Bachelor's degree or equivalent related research work experience
- 4-7 years of extensive clinical research experience in academic hospital university CRO or pharmaceutical/medical device company setting
- 2-4 years of clinical research leading and managing a team with supervisor or manager experience
- Master's degree preferred
- Expert knowledge of clinical trial management system and e-Regulatory system
- Ability to work collaboratively with physicians sponsors and research staff for protocol development and compliance
- Proven ability to develop research-related compliance policies in a hospital or institutional setting
- Effective verbal and written communication skills
- Strong logical thinking to interpret regulations solve problems and address research issues
- Analytical skills for productivity assessments
- Ability to adapt and perform under stressful conditions
- Leadership abilities to mentor supervisors managers and directors
- Ability to oversee creation and adherence of standard operating procedures
Job Duties
- Manage a dynamic team of clinical research coordinators ensuring efficient workload distribution and high-quality research operations
- Analyze the feasibility of potential clinical studies ensuring new studies are properly initiated and directly oversee the management and execution of trials
- Collaborate with the CTO director and stakeholders supporting the research mission of the hospital and execute strategic goals
- Develop strategic and innovative approaches to enhance early phase research program implementation and ensure alignment with current research regulations
- Maintain up-to-date and accurate clinical trial management systems including study status participant enrollment and study personnel
- Identify barriers to quality services compliance or ineffective processes and implement solutions
- Monitor recruitment targets develop recruitment options and work with physicians to support enrollment efforts
- Relay information to departmental staff including feedback collection and general discussion facilitation
- Coordinate training for physicians and research staff ensuring NCRI training requirements are met and current
- Work with investigators and study teams to meet trial targets milestones and ensure timely data entry adverse event reporting and protocol compliance
- Collaborate with hospital compliance for managing conflict-of-interest and patient health information protection issues
Job Criteria
Experience
Expert Level (7+ years)
Job Location
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