To develop, implement, test, and maintain database configuration for Cardiac Safety ECG receiving systems and Holter processing systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Implement new study database configuration in Cardiac Safety ECG receiving systems and Holter analysis systems. The systems include but may not be limited to the E-Scribe, H-Scribe, and MUSE systems.
Collaborate with Clinical Data Management, Project Management, Site Support, and Operations, to ensure timely system setup to meet contract and corporate deadlines.
Review new study setup materials to confirm database collection requirements. Review materials include the site equipment manual, equipment configuration forms, Data Collection Plan, and Project Management study requirement documents (SIP, Planning Meeting form, etc.).
Work with the Project Manager to determine which ERT office and system(s) are required to support the study.
Notify IT when system configuration or directory setup is required to support a new study.
Work with the Clinical Data Manager to utilize the Data Collection Plan to create system configuration forms.
Configure ECG receiving systems and Holter analysis systems to receive data from field ECG machines and Holter monitors.
Define ECG and Holter machine configuration to ensure absolute data collection compatibility and optimum efficiency.
Implement ECG or Holter sample process. Sample process scheduling must meet the needs of Site Support equipment programming and Operational deadlines.
Verify EXPERT setup and complete EXPERT sample mapping.
Test system configuration by submitting test data to the receiving and analysis systems.
Observe sample file as it moves through the receiving and analysis system to the ERT data management system.
Resolve database mapping or configuration issues and re-initiate process as required.
Notify study team when sample process is successfully completed.
Monitor EXPERT receiving systems and Archive directories for expected activity.
Compare daily activity to EXPERT activity and investigate count discrepancies.
Manage files rejected by EXPERT due to mapping or system configuration issues. This process must be expedited to support reporting turnaround requirements.
Review files that land in the Exceptions directory.
Review protocol and investigator information, EXPERT mapping table information, and EXPERT setup information to determine reason for rejection of the file.
Determine corrective action to resolve receipt count discrepancies and exception records. When necessary, contact Site Support and/or Customer Care to verify specific equipment programming.
Post incidents to Magic Solutions database when required.
Notify appropriate departments and confirm when specific personnel must perform corrective action.
Document resolution or exception process, including resolution to re-issue corrected files, and resolution of the exception files.
Track issues and provide metrics to department managers to ensure preventative solutions.
Involve IT and the EXPERT Development team when corrective action cannot be determined.
Manage ECG receiving system and Holter analysis User Accounts. This would include setting up new users, maintaining user accounts, and managing password expiration process where required.
Work with the Cardiac Systems Implementations team to maintain and present training information that describe configuration requirements for ECG equipment, Holter equipment, ECG receiving systems, Holter analysis systems, and mapping configuration process with EXPERT.
Participate in regular meetings to ensure that all personnel are current with procedures, activities, and project deadlines. These meetings include Project Assurance meetings and Cardiac Safety Operations Department meetings.
Support the evaluation and implementation of new/revised data systems and technologies to improve ERT services. This includes but is not limited to:
Participating in systems implementation teams
Establishing User Requirements
Conducting/documenting test scripts
Creating system SOPs
Completing all necessary training and proficiency testing related to the system release.
Assist in tracking error trends across applications to improve User Requirements and system upgrade management
Work with the Sales team to promote Diagnostic Services. Participate in on and off site presentations, demonstrations, tours, and training when required.
Bachelor Degree or equivocal experience required.
At least one year of previous ERT Cardiac Safety Operational or Project Assurance experience required.
Experience in utilizing Holter and ECG equipment preferred.
Experience in the functionality of Holter and ECG processing systems preferred.
Working EXPERT experience preferred.
Must demonstrate an aptitude for data collection, database configuration and mapping, systems implementation and systems management, and multi-site management.
Demonstrate excellence in problem solving skills and the ability to work effectively under pressure.
Excellent communication skills and effective presentation skills.
Knowledge of ECG and/or Holter endpoints and CPMP guidelines.
Knowledge of the pharmaceutical drug development process, including a general knowledge of Pharmaceutical Regulatory practices as they pERTain to use of electronic data collection and results reporting.