Mgr-Trial Monitoring
About The Position
The Manager, Trial Monitoring leads and oversees the clinical trial monitoring program for a diverse portfolio of studies, including complex, multi-site IND and IDE clinical research. The role collaborates with Principal Investigators, research teams, and monitoring staff to ensure St. Jude-sponsored research is conducted in accordance with study protocols, applicable regulations, GCP guidelines, institutional requirements, and SOPs. The Manager directly supervises and develops monitoring personnel, manages assignments and performance metrics, reviews monitoring plans and reports, and provides oversight of outsourced monitoring activities. The role develops methods, procedures, and systems to support data quality in a rapidly changing environment. The successful candidate has experience in vendor management, change management, and transformational leadership, and can lead teams through change, improve processes, strengthen vendor performance, and advance monitoring practices. The position also supports the development and management of clinical research protocols, study set-up through close-out, tracking of study documentation and milestones, institutional and NIH grant development, and coordination with internal and external stakeholders.
Requirements
- Bachelor's degree in a relevant area.
- At least 6 years of progressive experience in a relevant, comparable clinical research operations area.
- Experience with clinical research operations systems and processes, including their maintenance or implementation as applicable.
- Significant technical experience in an applicable area, such as research monitoring or regulatory documentation.
- Significant experience with relevant regulations and guidelines, including Good Clinical Practice and Office of Human Research Protections review and reporting requirements, and supporting institutional compliance.
- Demonstrated knowledge of study operations and oversight, including planning and managing study activities across sites.
- Ability to assess and ensure ICH GCP compliance in clinical research and to develop and implement institutional DSMPs and study-specific monitoring plans across sites and studies.
- Knowledge of regulatory, safety, and human subject protection considerations related to product development and clinical trial conduct.
- Strong critical-thinking, problem-solving, communication, collaboration, and influencing skills.
- Ability to manage people, establish goals, provide feedback, and hold team members accountable.
- Ability to lead projects and processes, anticipate roadblocks, and deliver high-quality results.
Nice To Haves
- Experience managing 1–2 people.
- Extensive experience leading projects or processes end to end, including resource planning and management and collaboration with internal cross-functional teams and external partners.
- Proven performance in an earlier role.
Responsibilities
- Oversee and coordinate monitoring program studies of all types, including complex, multi-site IND and IDE clinical research.
- Collaborate with Principal Investigators, research staff, and monitoring staff to ensure sponsored research complies with protocols, regulations, ICH/GCP guidelines, institutional data safety and monitoring plans, and SOPs.
- Supervise monitoring personnel, manage assignments and metrics, and mentor and guide team members.
- Review monitoring reports, tools, and templates; critique monitoring plans; and provide oversight of outsourced monitoring activities.
- Develop methods, procedures, systems, SOPs, and business processes that support data quality and the conduct of clinical protocols.
- Assist in developing and managing clinical research protocols for multiple disease teams, including data collection and reporting, record maintenance and communication, protocol issue resolution, and IRB engagement.
- Participate in set-up, planning, maintenance, and close-out of single- and multi-institutional national and international clinical trials.
- Track and oversee documentation, study status, and key milestones in CTMS, eTMF, and other systems and applications.
- Use tools, metrics, and reports throughout the study management lifecycle.
- Serve in an advisory role for institutional and NIH grant development.
- Liaise among Principal Investigators and study teams, internal bodies such as CTO, CTSRC, and IRB, and external bodies such as FDA, NIH, and pharmaceutical firms.
- Track resource allocations and serve as an escalation point for study- and staff-related issues.
- Engage in hiring, performance management, and other people processes.
- Perform other duties as assigned to meet departmental and institutional goals and objectives.
- Maintain regular and predictable attendance.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
