Program Manager of Clinical Research Systems
Columbia University New York, Clinical Trials Office
United States

Position Summary

Reporting directly to the Executive Director (the “Director”) of the Clinical Trials Office at Columbia University Irving Medical Center (“CUIMC”), the Program Manager of Clinical Research Systems (the “Manager”), assists the Director in overseeing the configuration, data management and quality assurance for all research systems in the CTO.

The successful candidate will be responsible for leading, developing, executing and maintaining the research systems within the Clinical Trials Office, and provide tactical and strategic support in the integration of the CTO systems with other systems, including EPIC.


Responsibilities

Duties and responsibilities of the Manager will include, but not limited to, the following:

    1. Collaborates with the CTO Management Team, CUIMC faculty and administration, NYPH administration, EPIC, EPIC Together, Sponsored Projects Administration (SPA), CUIMC IT, CUIT, and the Human Research Protections Office (HRPO) in meeting the institutional needs regarding clinical trial compliance, quality assurance, training and process-improvement goals.
    2. Manage a team of Research Systems Analysts and in the CTO
    1. Responsible for leading and executing on product implementations with the goal of driving client engagement and ensuring success for EPIC Research implementation.
    2. Lead new users through CTMS onboarding process through comprehensive planning by understanding the needs of the users.
    3. Serve as a leader and trusted advisor to a network of stakeholders throughout the implementation phases.
    4. Coordinate remote and on-site "go-live" support during the implementation process. Ascertain business and system needs in order to make tactical planning recommendations.
    5. Establish project teams, develop and execute project plans with the goal of ensuring maximum success.
    6. Create and deliver customer-facing reports (weekly status reports), visualizations and documentation.
    7. Continually look at ways to improve the implementation methodology in order to enhance customer experience. Coordinate and host regular customer conference calls for governance or trouble shooting with executive management level.
    8. After go-live, during transition phase, provide data to help identify any gaps in workflows
    9. Collaborate with CUMC IT, EPIC and EPIC Together in the design, planning, testing, evaluation, implementation, adoption, and customization of applications including IBM CTMS and the EPIC Research Module.
    10. Recommend solutions to enhance and maximize workflow for the practices.
    11. Lead and coordinate on-going support for entering clinical trials information into the CTMS and EPIC systems.
    12. Ensure standard operating procedures are consistently maintained on the CTMS and related EPIC Research Module systems.
    1. Provide training in the CTMS and EPIC Research systems to applicable personnel.
    2. Maintains strict data integrity and quality control standards for the CTO databases.
    3. Extracts data for publication, statistical reports, and other data collection requirements on tight deadlines.
    1. Must possess the ability to successfully complete Epic systems training requirements.

Minimum Qualifications

Bachelor’s degree or equivalent in education or experience and 5 years of related experience


Preferred Qualifications

  • Bachelor’s degree in finance, business management, or related field, or equivalent training/experience/years of related service. 

    1. Project management experience a plus.
    2. Understanding of healthcare systems and research systems a plus.
    3. Strong computer skills preferred, including Microsoft Office Suite.
    4. Demonstrate ability to understand clinical research and associated processes and applications.
    5. Excellent interpersonal and presentation skills.

Other Requirements

Excellent verbal, written and editorial communication skills with an attention to detail required.


Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

 


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