Regulatory Manager – Onsite/Hybrid, Nashville TN

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:

VICC – Clinical Trials 40

Job Summary:

Responsible for the efficient management of the VICC Clinical Trials Office Regulatory Team – directly managing 18 individuals. Provides in-depth knowledge, expertise, and ongoing support to regulatory and clinical research staff regarding the regulatory conduct of clinical research studies. Guides regulatory staff, setting and communicating priorities and performance standards. Stays current with new and revised standard operating procedures and regulations. Works with the VICC Clinical Trials Office leadership to align training and staff development, implementing new training programs to meet emerging/unmet needs.

Strongly preferred experience:
CCRP
Extensive management experience within healthcare sector
8-10 years of regulatory experience
HRRP experience

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Responsible for the efficient management of the VICC Clinical Trials Office Regulatory Team

• Provides expertise and leadership in the development, preparation and implementation of regulatory strategies to support cancer clinical trials
• Ensures the coordination of regulatory work to shepherd protocols through and open studies in a timely manner
• Oversees regulatory framework, determines pathways and options, and interacts with sponsors, agencies and other academic institutions

Ensures and guarantees regulatory compliance for VICC’s large and complex clinical trial portfolio

• Oversees and audits the creation, initiation, development, and revision of protocols, informed consents, and other study and clinical research documentation
• Approves protocol and document submissions to internal and external regulatory bodies (e.g. Institutional Review Board), confirming trials are consistent with approved proposals to open new studies

Manages study activations and regulatory activities for the VICC Clinical Trials Office

• Oversees regulatory data management activities and process maintenance of electronic regulatory files and binders with information pertinent to studying milestone progress (e.g., OnCore clinical trial management system, IRB databases, and internal/external spreadsheets and files).

• Reviews documentation to support regulatory filings and prepares annual progress reports for IRB renewal of ongoing studies

Prioritizes and manages workloads for the VICC Clinical Trials Office Regulatory Team

• Leads high-quality compliance reviews, including close-out and reporting
• Organizes team meetings, and actively and proactively participates with committees, task forces and ad hoc groups
• Leads clinical-specific training and development of staff, maintaining and improving quality assurance programs as needed

Education: Bachelor’s Degree3 Years

Experience: 3 Years

CCRP Certification Preferred

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: Directs activities to achieve operational plans with some near term effect on results of the department/area.* Problem Solving/ Complexity of work: Identifies issues, gathers facts to resolve technical and operational problems. * Breadth of Knowledge: Applies in-depth knowledge and skills of a professional/technical area and basic management knowledge to manage the work of the team.* Team Interaction: Leads a complex department with a focus on implementation. Typically executes on a short to medium term strategies.

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:

3 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