Mgr-Trial Monitoring

St. Jude Children's Research Hospital

12d•$94,640 - $169,520•Remote

About The Position

The Manager, Trial Monitoring leads and oversees the clinical trial monitoring program for a diverse portfolio of studies, including complex, multisite IND and IDE clinical research. The manager collaborates with Principal Investigators, research teams, and monitoring staff to ensure St. Jude-sponsored research follows study protocols, applicable regulations, ICH Good Clinical Practice guidelines, institutional requirements, and standard operating procedures. The role supervises and develops monitoring personnel; manages assignments, resources, and performance metrics; reviews monitoring plans, reports, tools, and templates; and provides oversight of outsourced monitoring activities. It develops methods, procedures, and systems to support monitoring data quality in a changing clinical research environment. The successful candidate brings experience in vendor and change management and transformational leadership, with the ability to guide teams through change, improve processes, strengthen vendor performance, and advance monitoring practices. The position also supports clinical research protocol management across disease teams, trial set-up and close-out, study documentation and milestone tracking, institutional and NIH grant development, and communication with internal and external stakeholders. It contributes to hiring, performance management, mentoring, and other people-management processes.

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 to the area.
Significant technical experience in a relevant 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 ability to think critically, draw insights from data, identify root causes, and solve complex problems independently.
Ability to adapt to change with resilience and flexibility.
Ability to communicate complex ideas to diverse audiences and influence others using facts and logic.
Ability to present and facilitate independently in senior-level meetings, structure information effectively, and address challenging questions.
Ability to set and achieve high targets, anticipate roadblocks, and maintain teams' focus on high-quality results.
Knowledge of clinical data management processes and tools, including data sourcing, compilation, and query handling.
Knowledge of study operations and oversight, and ability to plan and manage study activities across sites.
Ability to assess and ensure ICH GCP compliance during clinical research studies, contribute to site feasibility assessments, and develop and implement institutional DSMP and study-specific monitoring plans.
People-management skills, including setting goals, providing feedback, coaching, and supporting staff development and accountability.
Knowledge of regulatory, safety, and human-subject protection considerations in product development and clinical trial conduct.
Ability to interpret and guide application of relevant regulatory laws and safety and ethical requirements, and support compliance and documentation throughout clinical study design and conduct.
Proven performance in an earlier role.

Nice To Haves

Experience managing at least 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.
Experience in vendor management, change management, and transformational leadership.

Responsibilities

Assist with development and management of clinical research protocols for multiple disease teams, including data collection and reporting, record maintenance and communication, protocol issue resolution, and IRB engagement.
Participate in the 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.
Advise on development of institutional and NIH grants.
Liaise between Principal Investigators and study teams, internal bodies such as CTO, CTSRC, and IRB, and external bodies such as FDA, NIH, and pharmaceutical firms.
Develop, implement, and maintain standard operating procedures and business processes for conducting clinical protocols.
Mentor and guide team members and ensure timely resource availability to achieve outcomes.
Track resource allocations and serve as an escalation point for study- and staff-related issues.
Participate in hiring, performance management, and other people processes.
Oversee and coordinate the monitoring program for studies, including complex, multisite IND and IDE research.
Supervise monitoring personnel and manage their assignments and metrics.
Review monitoring reports, tools, and templates; critique monitoring plans; and oversee outsourced monitoring.
Develop methods, procedures, and systems to support monitoring data quality.
Maintain regular and predictable attendance.
Perform other duties as assigned to meet department and institutional goals and objectives.