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Mgr, Clinical System Informatics

Pharmaceutical Product Development (PPD)

United States

Summarized Purpose:

The IT Manager of Clinical Systems Informatics job responsibilities focus on championing the Clinical Trial Management System ( CTMS) to the organization's users, conducting training of the CTMS with users, assisting the finance department in effective reporting and utilization of the CTMS, addressing problems or limitations with CTMS raised by the organization's users, implementing processes that streamline reporting, and continually reviewing the CTMS to recommend updates and changes as needed. Also acts as a liaison for proper use and function of CTMS between all departments and organization's users. Travel to sites for training and/or implementation of CTMS may be necessary. Manages staff including work assignment, development of staff and performance management. Act as a liaison between IT and business leadership. Provides progress updates

and aligns IT with business. Assists IT and business leadership in understanding technical projects and solutions. Assists in process improvement and develops procedures. Coordinates enhancements to the CTMS system with external vendor(s) and internal IT department. Runs weekly CSI team meetings Summarized Purpose:

The IT Manager of Clinical Systems Informatics job responsibilities focus on championing the Clinical Trial Management System ( CTMS) to the organization's users, conducting training of the CTMS with users, assisting the finance department in effective reporting and utilization of the CTMS, addressing problems or limitations with CTMS raised by the organization's users, implementing processes that streamline reporting, and continually reviewing the CTMS to recommend updates and changes as needed. Also acts as a liaison for proper use and function of CTMS between all departments and organization's users. Travel to sites for training and/or implementation of CTMS may be necessary. Manages staff including work assignment, development of staff and performance management. Act as a liaison between IT and business leadership. Provides progress updates

and aligns IT with business. Assists IT and business leadership in understanding technical projects and solutions. Assists in process improvement and develops procedures. Coordinates enhancements to the CTMS system with external vendor(s) and internal IT department. Runs weekly CSI team meetings Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).

1 year of leadership responsibilities Maintains a thorough knowledge of the organization and adheres to all organizational standards. Keeps immediate supervisor well-informed of activities and recommends corrective actions. Identifies organizational needs, addresses any problems, and develops processes within the CTMS. Develops ideas, formulates and implements a plan for modifying the CTMS changes as needed; analyzes multiple approaches/solutions for a specific issue or problem within the CTMS. Works side by side, acting as a liaison in collaboration with the organization's users. Manages and resolves helpdesk tickets specific to CTMS issues and questions. Helps to develop, deliver, and manage the CTMS training plan for new staff and ongoing education for all CTMS users within the organization; Ensure training is effective through participant feedback with reevaluation and modification of training as needed. Assists in any conversion and training processes on the CTMS for new sites acquired within organization. Optimizes the CTMS to function efficiently and effectively within the organization. Manages the CTMS support staff to provide system maintenance and execute new development projects Coordinates and manages the testing and parallel runs of the CTMS new releases to ensure compatibility and identification of potential issues prior to acceptance of update. Assists in the rollout of system integrations involving the CTMS Participates and manages study design in the CTMS with all necessary departments within the organization. Works with internal IT and third party vendors to integrate new products with the CTMS.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).

1 year of leadership responsibilities Maintains a thorough knowledge of the organization and adheres to all organizational standards. Keeps immediate supervisor well-informed of activities and recommends corrective actions. Identifies organizational needs, addresses any problems, and develops processes within the CTMS. Develops ideas, formulates and implements a plan for modifying the CTMS changes as needed; analyzes multiple approaches/solutions for a specific issue or problem within the CTMS. Works side by side, acting as a liaison in collaboration with the organization's users. Manages and resolves helpdesk tickets specific to CTMS issues and questions. Helps to develop, deliver, and manage the CTMS training plan for new staff and ongoing education for all CTMS users within the organization; Ensure training is effective through participant feedback with reevaluation and modification of training as needed. Assists in any conversion and training processes on the CTMS for new sites acquired within organization. Optimizes the CTMS to function efficiently and effectively within the organization. Manages the CTMS support staff to provide system maintenance and execute new development projects Coordinates and manages the testing and parallel runs of the CTMS new releases to ensure compatibility and identification of potential issues prior to acceptance of update. Assists in the rollout of system integrations involving the CTMS Participates and manages study design in the CTMS with all necessary departments within the organization. Works with internal IT and third party vendors to integrate new products with the CTMS.

Job posted: 2021-03-09

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