Clinical Trials Manager

Discover Vanderbilt University Medical Center:  Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of diverse individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and where your diversity of culture, thinking, learning, and leading is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Organization:

VICTR

Job Summary:

Clinical Trials Manager – VICTR – Vanderbilt Coordinating Center (VCC)

JOB SUMMARY
In your pivotal role as a Clinical Trials Manager, you will be supporting the design and conduct of operational activities related to planning, implementing, executing, and reporting of multicenter clinical trials in accordance with standard operating procedures, Good Clinical Practice, and local and federal regulations. Ensure data accuracy across participating clinical research sites. You will direct long-range strategic planning for each clinical trial, including setting goals and objectives. Ensure that goals and milestones remain on track and develop and implements corrective action plans to improve performance when needed.

About the Department:
The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. The VCC first began in 1989 under the direct leadership of Dr. Gordon Bernard. Its initial focus was on providing coordinating center support for investigator-initiated trials overseen at Vanderbilt. In 2016, with the addition of several large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR) and due to an ever-growing need to provide more specialized, flexible support to Vanderbilt investigators, a need surfaced to reinstate the VCC. For more information, please visit https://vcc.vumc.org.

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KEY RESPONSIBILITIES

• Manages and operationally delivers 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.
• Ensures appropriate communication and ongoing leadership of assigned trial(s) by working in close collaboration with the sponsor and other functional team members.
• Identifies challenges to study timelines/deliverables and offers creative action plans to the team/sponsor.
• Maintains team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

TECHNICAL CAPABILITIES

STUDY DESIGN & DEVELOPMENT (INTERMEDIATE)

• Throughout the conceptual phase of the project, assist (as applicable) with protocol development from a scientific, statistical, regulatory, and administrative perspective. Assist in identifying, evaluating, and selecting national/global sites for Clinical Trial participation.  Work with Principal Investigator to identify clinical trial key collaborators and resources and assists these collaborators throughout the lifespan of the Clinical Trial.  These collaborators may include an independent Core Lab, Medical Safety Monitor(s), Biostatistician(s), Independent Randomization Reviewer(s), Radiologist(s), and any other applicable resources required by the Clinical Trial. With oversight from the Office of Contracts Management, facilitate the subcontracting process between VUMC and participating Clinical Trial sites. Work with the Principal Investigator to develop appropriate Clinical Trial committees and assist in meeting the ongoing needs of assigned committees.  These committees may include a Data, Safety, and Monitoring Board; Steering Committee; Clinical Improvement Committee; and Trial Operational Committee.

CLINICAL TRIAL IMPLEMENTATION (INTERMEDIATE)

• Within the regulations of the FDA and other governing bodies, implement processes for proper trial coordination at participating centers and individualize processes when necessary to ensure protocol compliance by accommodating unique workflows. Develop written, multicenter study plans including Standard Operating Procedures, Monitoring Plans, and Committee Charters to streamline clinical trial workflow, provide accountability, set milestones, and identify expectations to ensure the trial’s overall success. With oversight, serve as a resource for developing the initial Clinical Trial Agreement/Contract between VUMC and the Clinical Trial sponsor(s). Work directly with the Office of Sponsored Programs, Office of Contracts Management and with the appropriate contacts at outside institutions to ensure all applicable regulations are met during the initiation of the project. Use the project’s protocol to determine the content of the training materials, databases, data collection documents, monitoring plans, and other details that are trial specific. Create, distribute, and update (as necessary) all clinical trial training materials (i.e., videos, questionnaires, presentations, newsletters, etc.) for participating Clinical Trial sites.  May require travel to participating sites to conduct initial and/or ongoing training. Become familiar with current trends in technology, market pressures and resources, and leverage relationships with key stakeholders within the research community facilitate the project’s success.

TRIAL MANAGEMENT (INTERMEDIATE)

• Perform ongoing regulatory review for participating Clinical Trial sites to maintain compliance with applicable local, state, and federal laws and best practices. Maintain safety profile of the Clinical Trial by reviewing Serious Adverse Event reports, Protocol Deviations, and other unanticipated events that occur at Clinical Trial sites and ensure that events are reported to proper authorities in a timely manner. 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, amend, and maintaining electronic data-capture systems associated with all aspects of multicenter data collection and study workflow. Assist with electronic data-capture support and may oversee a project specific hotline where participants can receive assistance with regulatory needs, system support, clinical questions and/or receive enrollment support. Organize and/or attend committee meetings, collaborator meetings, and internal operational meetings related to the Clinical Trial (which may require travel). Troubleshoot recruitment problems, reporting problems and work with research coordinators and investigators at participating institutions to ensure compliance with project standards. Ensure that participating Clinical Trial sites remain compliant with data submission and other applicable reporting criteria before payments are issued according to their individual subcontracts. Compile data on trial activities and quality of reporting based on contractual terms, and compare this information when processing invoices from individual sites. Track and monitor expenditures against budget. Assist with progress report submissions to funding source and/or Program Director.

DATA MANAGEMENT (INTERMEDIATE)

• Incorporate automatic triggers into electronic data-capture systems to highlight issues in current datasets and generate queries when questions arise regarding data accuracy for each participating Clinical Trial site.  Communicate with the Principal Investigator, Site Investigators, and/or Clinical Trial committee members as needed regarding the status of Clinical Trial data by running frequent reports in identify gaps.  Develop and implement corrective action plans to encourage accurate and complete datasets. Oversee the verification process for the electronic data submitted from national/global Clinical Trial sites, which may also include the oversight of Clinical Research Associates who directly interact with the trial’s data. Oversee the project’s monitoring process where study data is compared to original source documentation to ensure data accuracy while incorporating applicable laws and guidance. Travel to Clinical Trial sites as necessary to verify data accuracy. Develop and incorporate centralized and local (i.e., on-site) data monitoring plans and methods to ensure that final trial data is accurate and complete before analysis and publication occur. Identify, assign, monitor, and maintain appropriate levels of internal and external user access to Clinical Trial related data and study materials. Develop standard processes for participating institutions surrounding the status of the project’s current dataset, compliance records, safety profile, and fiscal activities. Compile data, reports, and outcome to develop reports and presentations for various trial committees and sponsors that are reflective of current and future financial, safety, compliance, and enrollment milestones.

PROJECT LEADERSHIP (INTERMEDIATE)

• Responsible for establishing consistent methods for study communication keep project on track, foster collaboration, improve communication, and continually gather support from participating institutions. Actively demonstrate facilitative leadership to foster productive teamwork among Clinical Trial Site Investigators and their study staff, Clinical Trial collaborators, the Clinical Trial sponsor(s) and/or financial partners, applicable Clinical Trial committees, and the internal Clinical Trial team at Vanderbilt University Medical Center (which may include collaborators in Biostatistics, The Department of Medicine, the Section of Surgical Sciences, biomedical Informatics, Office of Contracts Management, Office of Sponsored Programs, Finance, the Human Research Protection Program, etc.). Leads CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities.

REQUIRED SKILLS

• Bachelor’s Degree
• 2 years relevant experience (Required)

Our professional administrative functions include critical supporting roles in information technology and informatics, finance, administration, legal and community affairs, human resources, communications and marketing, development, facilities, and many more.

At our growing health system, we support each other and encourage excellence among all who are part of our workforce. High-achieving employees stay at Vanderbilt Health for professional growth, appreciation of benefits, and a sense of community and purpose.

Core Accountabilities:

Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area. Team Interaction: Provides informal guidance and support to team members.

Core Capabilities :

Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one’s own communication style to suit different situations and audiences. Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees’ effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.

Position Qualifications:

Responsibilities:

Certifications:

Work Experience:

Relevant Work Experience

Experience Level:

2 years

Education:

Bachelor’s

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled