Manager, Clinical Trials - Vanderbilt University Medical Center
Nashville, TN
About the Job
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
Job Summary:
Leads research activities for the departments research initiatives. Manages and coordinates research studies and personnel.
Act as project manager for each study within their portfolio
Act as primary point of contact with the sponsor from feasibility through permanent closure
Collaborate/facilitate operations with study team and ancillary departments primarily in startup but throughout the life of the study
Lead study team and external stakeholders through startup
Stay abreast of status of each element of the study and escalate holdups and potential obstacles (primarily in startup but throughout the life of the study)
Prepare for and present in internal stakeholder meetings
Preferred experience:
Clinical trials experience, preferably cancer
.
KEY RESPONSIBILITIES
• Independently manage budgetary responsibilities and research contracts for clinical research faculty members
• Track budget for federal and non-federal grants, development funds and clinical trial studies
• Develop, negotiate and maintain contract administration
• Audit and review accounts throughout the year to ensure compliance with the NIH and prepare monthly variance analysis reports and track CME expenditures
• Manages staff supporting Clinical Trials/ Research activities for the department.
• Oversee implementation of reports for personnel and investigator funding
• Serve as liaison between the IRB and the department, obtaining necessary approvals for research projects
• May work other departments to develop and implement programs in support of the clinical trials/ research activities.
• Provide instruction on research protocols including interpretation of test results, observations, and related study data to physicians, nurses, professors, teachers, and technician involved.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.
TECHNICAL CAPABILITIES
• Medical Records Management (Expert): Knowledge of how and where to store and maintain basic records associated with job assignments.
• Research Administration (Expert): Knowledgeable on all phases in the lifecycle of a sponsored research project. Well versed in and able to assist researchers in reducing compliance risks and assisting in routine and specialized processes.
• Laboratory Practices (Expert): Is a recognized expert and authority in laboratory practices. Occupies the position that is the last internal resource for support or direction. Expected, as a result of the position, to have the ultimate knowledge, control, influence, and/or jurisdiction in laboratory practices. Demonstrates industry leadership in outside professional organizations and forums. Takes a lead role in developing best practices for the organization.
Our Academic Enterprise is one of the nation’s longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.
World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.
Aligning with Vanderbilt Health’s Strategic Directions , the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.
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 :
5 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
Organization:
VICC - Clinical Trials
Job Summary:
Leads research activities for the departments research initiatives. Manages and coordinates research studies and personnel.
Act as project manager for each study within their portfolio
Act as primary point of contact with the sponsor from feasibility through permanent closure
Collaborate/facilitate operations with study team and ancillary departments primarily in startup but throughout the life of the study
Lead study team and external stakeholders through startup
Stay abreast of status of each element of the study and escalate holdups and potential obstacles (primarily in startup but throughout the life of the study)
Prepare for and present in internal stakeholder meetings
Preferred experience:
Clinical trials experience, preferably cancer
.
KEY RESPONSIBILITIES
• Independently manage budgetary responsibilities and research contracts for clinical research faculty members
• Track budget for federal and non-federal grants, development funds and clinical trial studies
• Develop, negotiate and maintain contract administration
• Audit and review accounts throughout the year to ensure compliance with the NIH and prepare monthly variance analysis reports and track CME expenditures
• Manages staff supporting Clinical Trials/ Research activities for the department.
• Oversee implementation of reports for personnel and investigator funding
• Serve as liaison between the IRB and the department, obtaining necessary approvals for research projects
• May work other departments to develop and implement programs in support of the clinical trials/ research activities.
• Provide instruction on research protocols including interpretation of test results, observations, and related study data to physicians, nurses, professors, teachers, and technician involved.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.
TECHNICAL CAPABILITIES
• Medical Records Management (Expert): Knowledge of how and where to store and maintain basic records associated with job assignments.
• Research Administration (Expert): Knowledgeable on all phases in the lifecycle of a sponsored research project. Well versed in and able to assist researchers in reducing compliance risks and assisting in routine and specialized processes.
• Laboratory Practices (Expert): Is a recognized expert and authority in laboratory practices. Occupies the position that is the last internal resource for support or direction. Expected, as a result of the position, to have the ultimate knowledge, control, influence, and/or jurisdiction in laboratory practices. Demonstrates industry leadership in outside professional organizations and forums. Takes a lead role in developing best practices for the organization.
Our Academic Enterprise is one of the nation’s longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.
World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.
Aligning with Vanderbilt Health’s Strategic Directions , the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.
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 :
5 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
Source : Vanderbilt University Medical Center