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.

The Manager-Trial Monitoring is responsible for overseeing and coordinating the monitoring program studies of all types, including complex, multiple-site Investigational New Drugs (IND) and/or Investigational Device Exemptions (IDE) clinical research studies. Collaborates with Principal Investigators, research staff and other monitoring staff to ensure that St. Jude sponsored clinical research is conducted per protocol, and is compliant with federal clinical research regulations, the International Conference on Harmonization Good Clinical Practices (ICH/GCP) guidelines, the institutional data safety and monitoring plan, and all applicable SOPs. Directly responsible for the supervision, assignments, and metrics of clinical research monitoring personnel. Reviews monitoring reports, tools, and templates. Critiques monitoring plans. Provides vendor oversight when monitoring is outsourced. Develops methods, procedures, and systems to support data quality in monitoring in a rapidly changing 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.

Minimum Education and/or Training:

• Bachelor's degree in relevant area required.

Minimum Experience:

• 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.

Licensure, Registration and/or Certification Required by Law:

• None

Licensure, Registration and/or Certification Required by SJCRH Only:

• None

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. Solves problems quickly by identifying the root causes. Encourages others to see the opportunities ahead amidst changing circumstances even when the details have not been finalized.
• Skills in communicating complex ideas effectively to diverse audiences and influence others to see different points of view.
• Leverages advanced knowledge/ skills within area to identify and implement new/improved processes/approaches
• Can present/facilitate independently in senior-level meetings. Presents information as a structured story and anticipates questions well. Addresses difficult questions and challenges effectively. Able to effectively influence others using facts and logic.
• Focus on setting high targets, following through with actions, and achieving results. Ability to anticipate roadblocks and circumvent challenges.
• Keeps teams energized and focused on high-quality results. Thinks long-term in building and executing metrics-driven plans and stretch goals for St. Jude. Builds structures and processes with clear lines of authority and accountability so teams know what they are empowered and accountable to do.
• Skills in clinical data management processes/tools to source and compile data with an understanding of potential data needs.
• Learns on the job and applies skills in routine tasks and activities; delivers under supervision and guidance
• Applies basic understanding of clinical data management processes, tools, & concepts to support data sourcing and compilation for assigned studies/areas with guidance. Addresses data queries and requirements based on knowledge of origin, flow, and management of data through a clinical study.
• Knowledge of study operations and oversight; Ability to plan and manage study activities across sites.
• Assesses and ensures ICH GCP compliance throughout the conduct of clinical research studies within own area/ site. Provides input and guidance for site assessment around feasibility. Develops and implements institutional DSMP and study-specific monitoring plans across sites and studies.
• Skills in managing people, establishing goals and objectives, giving feedback and having frequent career conversations.
• Is able to apply knowledge/skills within own area to deliver tasks with limited guidance
• Able to deliver results through others by setting stretch goals and holding them accountable. Coaches team members with concrete feedback and improvement ideas, including addressing employee relations concerns. Explores opportunities for development of direct reports that makes their work enriching, empowers them, and stretches their growth in lateral areas.
• Knowledge of regulatory, safety, and/or human subject protection considerations in relation to product development and/or clinical trial conduct.
• Applies knowledge of regulatory aspects related to investigational product development, protocol approval, and/or risk assessment processes. Supports regulatory compliance and documentation during study design and conduct across phases throughout the development life cycle. Understands, interprets, and guides application of relevant regulatory laws and safety and ethical requirements across clinical research teams.

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. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $94,640 - $169,520 per year for the role of Mgr-Trial Monitoring.

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