Clinical Research Systems Director

Job Title:

Clinical Research Systems Director

Job Description

The Clinical Research Systems Director leads the strategy, implementation, and ongoing optimization of enterprise-wide clinical research systems. This role oversees multiple platforms that support clinical trials, ensures seamless integration between systems, and drives process standardization to enhance efficiency, data quality, and compliance across the research enterprise.

Responsibilities

+ Initiate new clinical research systems projects and manage end-to-end implementation and integration processes, including planning, execution, and post-implementation review.

+ Manage resource allocation for system-related projects, ensuring appropriate staffing, timelines, and budgets are aligned with organizational priorities.

+ Lead process mapping and procedure documentation for clinical research systems to standardize workflows and promote operational efficiency.

+ Coordinate and oversee user acceptance testing to validate system functionality, identify issues, and ensure solutions meet stakeholder needs.

+ Develop and distribute system announcements and communications to keep users informed about updates, enhancements, and changes.

+ Serve as lead administrator for the Clinical Trial Management System (CTMS), overseeing the team that creates and monitors user accounts, ensures proper system use, and supports complete and accurate data entry.

+ Provide regular and ad hoc reports from the CTMS to leadership to support decision-making, performance monitoring, and compliance tracking.

+ Oversee the update and enhancement of the CTMS to include a financial module that streamlines pre-award and post-award management activities for clinical trials.

+ Direct and manage the integration of a new subject remuneration system with the CTMS to improve coordinator workflows and reduce duplicative data entry.

+ Serve as lead administrator for the enterprise-wide subject payment system, overseeing the team that creates and monitors user accounts, approves transactions, and ensures adequate card supply for research participants.

+ Act as lead administrator for the Institutional Review Board (IRB) review and submission system, overseeing system upgrades, enhancements, and quality assurance activities.

+ Collaborate with external vendors and internal stakeholders to plan and implement system upgrades and enhancements for the IRB submission platform and other research systems.

+ Liaise and collaborate with cross-functional teams in planning and implementing projects to ensure appropriate development, integration, and support of research systems across the enterprise.

+ Develop written standardized processes and operating procedures for all systems-related activities to promote consistency, compliance, and efficiency.

+ Collaborate in the development, configuration, and support of Epic tools related to the clinical research enterprise across the organization.

+ Provide leadership, guidance, and oversight to clinical research systems project managers, ensuring effective project delivery and professional development.

+ Promote a culture of continuous improvement by identifying opportunities to enhance system functionality, user experience, and operational workflows.

+ Ensure that all systems and processes comply with applicable regulations, institutional policies, and best practices for clinical research.

Essential Skills

+ 5-10 years of experience in project management with a strong systems focus, preferably in a clinical research environment.

+ Knowledge of clinical research systems, including Clinical Trial Management Systems (CTMS) and related platforms such as Florence eBinder.

+ Hands-on understanding and experience using CTMS platforms and associated technologies.

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Experience with clinical trial operations and workflows, including subject remuneration and financial management processes.

+ Familiarity with Epic and its tools related to clinical research.

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Experience with implementation and integration of clinical research systems, including tools such as OnCore or similar CTMS solutions.

+ Strong background in clinical research and electronic medical record (EMR)…