Senior Manager,Clinical Research Systems

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

City of Hope strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced. City of Hope is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

Requisition ID: 10313

Job Title: Senior Manager, Clinical Research Systems

Position Summary and Key Responsibilities:

Reporting to the Director of Research Applications and Data Management (RADM), the Clinical Research System Manager is the primary point of contact for OnCore CTMS-related activities at City of Hope and for the research business needs in the Epic EMR. The Clinical Research System Manager is responsible for working with all levels of staff to improve the functionality and use of OnCore. Responsible for the oversight and coordination of all activities that involve OnCore use in the planning, tracking, reporting and execution of City of Hope's clinical trials. This position will lead and manage OnCore usage throughout the pre-implementation and implementation process. This includes a leading role in the implementation of OnCore and the transition from current practices inherent in MIDAS, the COH homegrown clinical trials management system. The Manager will be responsible for administrative leadership, policy and procedure development, operational oversight, training and support to system users. This includes managing the post-implementation usage, identifying required system modifications, new opportunities to enhance the usefulness of existing technologies and adding appropriate new technologies. Will lead and develop a team dedicated to the business ownership and support of the OnCore CTMS and research business support of the Epic EMR system.

Essential Functions:

OnCore Implementation

  • Act as a lead individual in the implementation of OnCore, working closely with vendors, ITS, departments, user groups and leadership in identifying data sources, integrating systems, defining roles and responsibilities, refining user interfaces.
  • Responsible for milestone and deliverable tracking, and at acting as main point of contact for COH during the system pre-implementation and implementation.
  • Manages the post-implementation usage, identifying required system modifications, new opportunities to enhance the usefulness of existing technologies and adding appropriate new technologies.

OnCore and Epic Business Support

  • Works with other IT support staff involved in systems maintenance as required.
  • Works closely with the vendor to understand product roadmap, timelines, and impact of upcoming product releases.
  • Provides helpdesk support and resolve problems to the end user's satisfaction. Monitors Service Desk for tickets assigned to the queue.
  • Monitors and responds quickly and effectively to requests received.
  • Supports end users as the internal Subject Matter Expert for technical aspects such as integration with other systems.
  • Leads the configuration of OnCore for use in clinical research.
  • Responsible for developing and providing training to end users and assessing effectiveness of training, including updating documentation when system upgrades or changes occur.
  • Collects end user feedback and develops system customization requests and use cases.
  • Oversees processing and approval of user access requests, including determination of appropriate privilege level(s) based on job requirements.
  • Produces reports and metrics for leadership and others as needed.
  • Work with end users to develop reports to meet operational needs and ensure proper management of clinical research.
  • Responsible for the maintenance and running of all Cancer Center Data Tables 3 and 4.
  • Serves as liaison between leadership, IT and end users to assure cohesive approach to OnCore use. Works internally with other departments to ensure appropriate and timely OnCore training for end users.

OnCore and Epic Process Management

  • Develops and maintains standard operating procedures (SOPs) and workflows that govern the use of OnCore across City of Hope
  • Collects end user feedback and develops system customization requests and use cases.
  • Identifies and implements process improvements to enhance OnCore functionality and use.
  • Works closely with researchers, business Managers and management. Attends regular research-related meetings to assist with identifying opportunities to improve clinical trials research, patient care, patient safety and operating efficiency.
  • Oversees support of workflows developed as part of the implementation of OnCore.Works closely with IT team lead to ensure that modifications in workflows are regularly communicated and documented.
  • Establish and maintain policies and procedures for quality control and quality assurance of operational data in OnCore.
  • Coordinate with theClinical Trials Office andResearch Protections unitregarding data needs for quality assurance of clinical trials and clinical research.

Personnel Management

  • Work on identifying areas requiring process improvement or compliance, and collaboratively develop solutions.
  • Work with direct reports to resolve personnel issues.
  • Attend and participate in departmental staff meetings.
  • Create new job descriptions with distinct roles and responsibilities for existing management and staff positions (with assistance from HR).
  • Support staff training, education and development.
  • Recruit and retain high quality staff members.
  • Conduct performance appraisal of direct staff using input from others where applicable.
  • Maintain effective communication with supervisors, program leaders, faculty, managers and staff.

Performs other related duties as assigned or requested.

Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.

Performs other related duties as assigned or requested.

Minimum Education and Skills Required for Consideration:

  • Bachelor's Degree in life sciences or IT related discipline required.
  • Five to Seven years of experience in clinical research for drug or treatment development.
  • Experience with clinical trial management / clinical operations software systems.
  • Previous experience designing and delivering software training.
  • Comprehensive Cancer Center Experience a plus.
  • Experience in academic or research environment preferred.
  • Strong written and oral communication skills, attention to detail, customer service orientation and proven ability to perform work accurately and efficiently. Outstanding work ethic and excellent attendance record.
  • Demonstrated ability to work independently and with a team. Excellent organizational and analytic skills, with the proven ability to multi-task, trouble shoot and prioritize work.
  • Demonstrated knowledge regarding requirements for research involving human subjects and or clinical background and experience. Experience with clinical trials financial management preferred for study calendar creation.
  • Knowledge of MS Office suite, required.
  • Experience with CTMS required, experience with OnCore strongly preferred.

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