Clinical Trial Management System - Business Support Specialist

IQVIA•Parsippany, NJ

About The Position

This role is responsible for supporting any system supported by Clinical Trials Management Solutions team. This mainly includes study build activities within the Clinical Trial Management System (CTMS) by troubleshooting issues, ensuring the quality of clinical trial day, and addressing any issues in integrating the CTMS into other systems. This role will also participate in operational strategy project as related to the CTMS.

Requirements

Bachelor's Degree or equivalent education required; advanced degree preferred.
3-5 years of experience; preferably in the clinical trial, pharma, or other related industry.
Demonstrated knowledge of clinical development process, global clinical operations, and strategic planning, required
Excellent Problem solving and communication skills.
Oracle SQL experience, required.
Prior experience with Medidata, Siebel, or other CTMS system, required.
Knowledge of Clinical Trial Management process, required.
Proficient with MS Office Suite, particularly Visio & Excel.

Responsibilities

Work with the study teams and other partners to facilitate the study build process. This includes: Study, country, site, and institution records.
Create and set up templates to include health authority, IRB/IEC, Financial Disclosure, Subject Visits, Visit/Trip Reports.
Update system dropdown values.
Perform administrative tasks in the system such as user administration, assignments, configuration, parameters, etc.
Create and support payment, visit schedule, deviation, and other study functions.
Facilitate and troubleshoot integration issues between CTMS and other applications.
Provide general business support for CTMS and other applications used by the Clinical Trial Management Solutions Team.
Lead User Acceptance Testing (UAT) activities.
Lead analysis of large clinical data sets and create/generate reports.
Create and run SQL queries.
Support ticket generation and maintenance.
Create and maintain reference and training materials/documentation.