Operations Technical Manager

To develop, implement, test, and maintain database configuration for Cardiac Safety ECG receiving systems and Holter processing systems.

Clario is a 50+ year old company that delivers industry leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what’s possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence.

The Operations Technical Manager will develop, implement, test, and maintain database configuration for Cardiac Safety ECG receiving systems and Holter processing systems.

What you’ll be doing:

• Implement new study database configuration in Cardiac Safety ECG receiving systems, ABPM systems and Holter analysis 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 Clario 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, ABPM and Holter analysis systems to receive data from field ECG machines and Holter monitors. 
• Define ECG, ABPM, and Holter machine configuration to ensure absolute data collection compatibility and optimum efficiency. ​
• Implement ECG, ABPM or Holter sample process. Sample process scheduling must meet the needs of Site Support equipment programming and Operational deadlines. 
• Verify clinical setup and complete 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 Clario 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 receiving systems and Archive directories for expected activity. 
• Compare daily activity to system activity and investigate count discrepancies. 
• Manage files rejected by system 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, system mapping table information, and system 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 Clario 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, ABPM equipment, Holter equipment, ECG receiving systems, Holter analysis systems, and mapping configuration process within the systems. 
• 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 Clario 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.

Other Duties and Responsibilities:

• Participate in department budget development and implementation. 
• Other related projects and duties as assigned.

What we look for:

Education:

• Bachelor’s degree or equivocal experience required.

Experience:

• At least one year of previous 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. 
• 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. 
• Experience in SOP development.

EEO Statement

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract. The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.