Clinical Trials Manager

Vanderbilt Health - Nashville, TN

Full-time - Mid Level

Nashville, TN

Hospitals

About the position

As a Clinical Trials Manager at Vanderbilt Health, you will play a crucial role in supporting the design and execution of multicenter clinical trials. Your responsibilities will encompass planning, implementing, executing, and reporting on these trials in accordance with established standard operating procedures, Good Clinical Practice (GCP), and relevant local and federal regulations. You will ensure data accuracy across various clinical research sites and will be responsible for directing long-range strategic planning for each trial, including setting specific goals and objectives. It will be your duty to ensure that these goals and milestones are met, and to develop and implement corrective action plans to enhance performance when necessary. The Vanderbilt Coordinating Center (VCC), where this position is based, provides comprehensive support for a wide range of clinical and translational research projects. Established in 1989, the VCC has evolved to meet the growing needs of Vanderbilt investigators, particularly with the addition of large, innovative clinical trial grants. As a Clinical Trials Manager, you will manage and operationally deliver clinical elements within trials, which includes site selection, start-up, enrollment management, site engagement, monitoring planning and execution, regulatory documentation, data cleaning activities, and trial close-out. You will work closely with sponsors and other functional team members to ensure effective communication and leadership throughout the trial process. In this role, you will also be responsible for identifying challenges to study timelines and deliverables, proposing creative action plans, and maintaining team focus on study priorities through efficient cross-functional partnerships. Your expertise will be essential in ensuring compliance with applicable regulations and best practices, as well as in developing and maintaining electronic data-capture systems associated with multicenter data collection and study workflow. You will also oversee the verification process for electronic data submitted from clinical trial sites, ensuring that data accuracy is maintained throughout the trial lifecycle.

Responsibilities

• Manage and operationally deliver clinical elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, regulatory documentation, data cleaning activities and close-out.
• Ensure appropriate communication and ongoing leadership of assigned trial(s) by working in close collaboration with the sponsor and other functional team members.
• Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor.
• Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction.
• Assist with protocol development from a scientific, statistical, regulatory, and administrative perspective during the conceptual phase of the project.
• Implement processes for proper trial coordination at participating centers and individualize processes when necessary to ensure protocol compliance.
• Develop written, multicenter study plans including Standard Operating Procedures, Monitoring Plans, and Committee Charters to streamline clinical trial workflow.
• Perform ongoing regulatory review for participating Clinical Trial sites to maintain compliance with applicable local, state, and federal laws and best practices.
• Oversee continued institutional approval and applicable amendments at participating Clinical Trial sites that involve Institutional Review Boards and/or outside Contracts and Grants Offices.
• Develop and implement corrective action plans to encourage accurate and complete datasets.

Requirements

• Bachelor's Degree in a relevant field.
• Minimum of 2 years of relevant experience in clinical trials management or a related area.

Nice-to-haves

• Experience with electronic data-capture systems and data management processes.
• Familiarity with regulatory requirements and compliance in clinical trials.
• Strong communication and leadership skills to foster collaboration among diverse teams.

Benefits

• Comprehensive health insurance coverage.
• 401k retirement savings plan with employer matching.
• Paid time off and holidays.
• Opportunities for continued education and professional development.
• Support for work-life balance through flexible scheduling options.