The Dir-Clinical Research Quality Management & Education is responsible for the development and implementation clinical research education and quality management program strategies that embrace and enhance the quality of SJ Clinical Research. Must work across several cross-functional areas to achieve results, be well versed in the development of educational curriculum and the application of ICH GCP Quality Management principles.

Job Responsibilities:

• Lead and manage large/critical complex areas/teams within clinical research regulatory/compliance.
• Propose innovative & differentiating capabilities/procedures within clinical research regulatory/compliance (e.g., compliance programs, policies, and procedures; institutional regulatory processes for submission; regulatory/ scientific/ safety reviews) and oversee implementation and adoption.
• Define operational plans and oversee development and execution in line with objectives.
• Manage scope, schedule, and resources to ensure work is delivered in accordance with research needs, clinical project timelines, and established quality standards while eliminating risks.
• Collaborate with cross-functional leadership teams and external stakeholders (e.g., government regulatory authorities and agencies- DHHS, NIH, FDA, OHRP, OBA, RAC, RAC, OCR, etc.) to optimize clinical research outcomes.
• Lead systems for governance, monitoring, review, and control of processes and functions performed by clinical research support teams (e.g., trial conduct, safety data monitoring/reporting; technical file maintenance; regulatory submission management & deficiency/issue response; regulatory audits & site visits; regulatory compliance training and oversight).
• Guide budget management for regulatory initiatives.
• Actively drive processes for team management in terms of goal setting, performance, training and development, and engagement.
• 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: 10+ significant experience in a related area (e.g., clinical quality, clinical regulatory compliance) with experience managing large teams and/or critical complex functional area teams with focus on both achievement of objectives as well as critical skill-building.

• Experience working with systems/processes related to clinical research regulatory/quality aspects and their maintenance/implementation, as applicable to own area.
• Significant experience working with relevant regulations and guidelines, and driving institutional compliance.
• Experience having led large-scale projects/processes through to implementation.
• Experience with operational mgmt., budget planning, & stakeholder and resource management.
• Prior experience in building external connections with peers, emerging technology and regulatory communities, and expert networks.
• Proven performance in earlier role.

Special Skills, Knowledge and Abilities:

List pertinent skills, knowledge and abilities the person should have to be successful in the job.

• Shows strong skills in thinking critically with a systemic view.
• Shows expertise in taking a structured approach to analyze and resolve issues.
• Able to distinguish between different sets of issues, set priorities, and make decisions.
• Builds internal connections and external partnerships across executive/leadership levels.
• Strategically understands stakeholder needs and manages expectations and relationships on a regular basis.
• Can handle highly sensitive or tough situations with social and emotional grace and maturity.
• Models resourcefulness by reaching out to people within and outside functional groups to get work done effectively.
• Keeps large teams/ departments energized and focused on high-quality results.
• Builds systems, processes, and capabilities that can set and deliver a high-performance culture.
• Supports creation/implementation of data management plans with understanding of site/study data sourcing techniques and overall compilation.
• Independently assists data management tasks/processes in line with study-related data plans.
• Identifies and resolves data queries and requirements based on knowledge of origin, flow, and management of data through a clinical study.
• Ensures compliance with SOPs related to data quality within assigned studies.
• Drives and monitors clear goal setting, accountability, and feedback for the department (and matrixed teams).
• Guides performance of direct reports (or indirect if managing people indirectly) through coaching and development.
• Consistently evaluates and addresses the team's overarching development needs in line with the talent strategy.
• Advises cross-functional leadership around regulatory, safety, & ethical aspects for successful achievement of clinical research objectives.
• Provides guidance and training to internal staff, investigators, and other stakeholders about regulatory aspects and related best practices.
• Provides regulatory inputs to investigational product development and life cycle management plans.
• Develops and implements global strategies that optimize the regulatory, safety, & ethical outcomes of clinical research.
• Applies scientific principles and concepts in the development and/or review of clinical study protocols.
• Proposes/utilizes appropriate technologies and approaches for the successful conduct of clinical studies in line with research objectives and compliance requirements.
• Identifies endpoints (primary & secondary) to measure outcomes and provides ongoing technical guidance.

Compensation

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Diversity, Equity and Inclusion

St. Jude Children's Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world-regardless of race, religion or a family's ability to pay. Learn more about our history and commitment.

Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our Diversity, Equity and Inclusion Report to learn about the hospital's roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.

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