The Senior Trial Informatics Analyst supports the administration of the clinical systems and tools utilized by Development Operations. The Informatics Senior Analyst II ensures standardization in the process for collection of metrics and data. The Senior Analyst II ensures the information is provided to the business in a format that can enable informed decision making. The Informatics Senior Analyst II supports the technical oversight of all clinical systems which may include setting up and monitoring interfaces with external Partner CRO’s, vendor systems, Partner Departments, and working with IT Technical Team on user enhancements and updates.

Essential Functions of the Job (Key responsibilities)

• Support the administration of the Client CTMS system – Oracle-Siebel.
• Support the administration of reporting systems and prepare/ configure metric reports as required.
• Work with clinical study teams to ensure the accuracy of data in clinical systems and assist in managing data discrepancies regarding system integrations.
• Provide support, under the direction of the Informatics Manager, to clinical systems (CTMS, psiXchange Administration, Veeva eTMF, and GoBalto and other Feasibility tools), End-users, including receipt, evaluation and recommendation for all issue/enhancement requests.
• Process Request Tickets, and Incident Report tickets as received in the Systems Support Queue in support of Clinical systems.
• Provide User Assistance including Hands-on training support as required.
• Monitor and Support the CTMS Integration functionality and administration with Client partner Contract Research Organizations (CRO’s) to ensure data flow, record and field mapping, and record match-ups are occurring as expected.
• Monitor and Support CTMS integration with Interactive Response Technology (IRT) partner for Study Subject and Treatment data flow and reconciliation as requested by Study Teams and IRT Support.
• Monitor and Support CTMS integration with Pharmacovigilance partner department for Site Contact and Ethic Committee contact information to flow through the Safety SUSAR Distribution system.
• Collaborate with the central IT technical team as needed to support system enhancement configurations for integrations with partner CRO’s and partner departments on integrated systems.
• Support the development of training material/user manuals/learning solutions for clinical systems.
• Assist with site identification and feasibility, including technical support for GoBalto/Oracle Select, Zaidyn System, SharePoint support, to obtain information and reporting output to Feasibility Team and Clinical Study teams for evaluation.
• Provide SharePoint Site Administration support to Clinical Study Support Team Sites and pages as needed or assigned by Department SharePoint Owner(s).
• Serves as the POC for CTMS Data Quality and CRO integration data merges.
• Support study teams and Dev Ops Leadership in making data-driven decisions to optimize clinical trial recruitment and Increase efficiency of study start up activities.
• Serve as Ad-hoc member on Business and Department meetings for technical consultation, assistance with data conversions and mapping, and to advise on other technical solutions as needed.

Skills Required:

• General knowledge of and experience working in a GCP environment
• Demonstrated communication, influencing, collaboration and technical writing skills
• Strong interpersonal skills and knowledge depth of subject matter to converse with vendors and internal functions or departments
• Knowledge/understanding of complex IT system integrations, secured data transfer, mapped fields, data tables, formulas, and basic knowledge of HTML
• Knowledge of IT Knowledgebase and Helpdesk Ticketing and Reporting systems.
• Demonstrated problem solving and strategic thinking skills
• Goal oriented, self-starter with proven ability to work independently
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines
• Comfort with ambiguity; ability to act without having the total picture

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor Degree in an IT or scientific field.
• Minimum 2 years of experience in the pharmaceutical industry related to support of clinical systems.
• General knowledge of and experience working in a GCP environment.
• Demonstrate communication and technical writing skills.
• Strong computer and analytical thinking skills.
• Goal oriented, self-starter with proven ability to work independently.
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com