[Hiring] Manager, Trial Monitoring @St. Jude Children's Research Hospital

Role Description

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. This 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 supervises and develops monitoring personnel, manages assignments and performance metrics, reviews monitoring plans and reports, and provides oversight of outsourced monitoring activities. The successful candidate must have demonstrated experience in vendor management, change management, and transformational leadership, with the ability to lead teams through change, improve processes, strengthen vendor performance, and advance monitoring practices in an evolving clinical research environment.

Job Responsibilities

• Assist in development and management of clinical research protocols for multiple disease teams in compliance with regulatory requirements (e.g., data collection and reporting, record maintenance and communication, protocol issue resolution, IRB engagement).
• Participate in set-up, planning, maintenance, and close-out of both single and multi-institutional national and international clinical trials.
• Track and oversee documentation, study status and key milestones within CTMS, eTMF, and other systems and applications as needed.
• Utilize tools, metrics, and reports as part of the full study management lifecycle.
• Serve in an advisory role for development of institutional and NIH (National Institutes of Health) grants.
• Act as a liaison between the Principal Investigators (study teams), internal bodies (e.g., CTO, CTSRC, IRB), and external bodies (e.g., FDA, NIH, pharmaceutical firms).
• Develop, implement, and maintain standard operating procedures and business processes for conduct of clinical protocols.
• Mentor and guide team members and ensure timely resource availability for accomplishment of outcomes.
• Track resource allocations and act as an escalation point for both study and staff-related issues.
• Engage in hiring, performance management, and other people processes.
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Maintains regular and predictable attendance.

Qualifications

• Bachelor's degree in relevant area required.

Requirements

• Minimum Requirement: 6+ progressive years of experience in a relevant comparable clinical research operations area including experience managing at least 1-2 people preferred.
• Experience working with Cl. Res. Ops. systems/processes and their maintenance/implementation, as applicable to own area.
• Significant technical experience in area (e.g., research monitoring, regulatory documentation, etc.).
• Significant experience working with relevant regulations and guidelines (e.g., Good Clinical Practice Guidelines, Office of Human Research Protections review and reporting requirements) and supporting institutional compliance.
• Extensive experience leading projects/processes end to end including resource planning and management, and communication and collaboration with internal cross-functional teams and external partners preferred.
• Proven performance in earlier role.

Special Skills, Knowledge and Abilities

• Ability to think critically, draw insights and connect the dots.
• Openness to change and adapting to changing times with resilience and flexibility.
• Demonstrates strong knowledge/skills within area on a consistent basis to solve complex problems independently.
• Able to draw insights from different sets of data and quickly understand why issues are happening.
• Skills in communicating complex ideas effectively to diverse audiences and influence others to see different points of view.
• Focus on setting high targets, following through with actions, and achieving results.
• Skills in clinical data management processes/tools to source and compile data with an understanding of potential data needs.
• Knowledge of study operations and oversight; Ability to plan and manage study activities across sites.
• Knowledge of regulatory, safety, and/or human subject protection considerations in relation to product development and/or clinical trial conduct.

Compensation

In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. A reasonable estimate of the current salary range is $94,640 - $169,520 per year for the role of Mgr-Trial Monitoring.

Company Description

St. Jude is an Equal Opportunity Employer. St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities.