Clinical Process and Systems Specialist at IQVIA

Job Overview
Perform a variety of administrative tasks in support of clinical trials and assist in performing clinical procedures and systems required to collect data on patients enrolled and/or seeking enrollment in clinical studies. Provide a wide range of process and technical support for IQVIA technology used in clinical trials; act as the first line of support for technical issues and related processes dependent upon the technology. Work directly with product management and end users to ensure that systems are properly engineered, configured, maintained and closed out, and provide guidance to users as required for successful use of IQVIA technology products. Provide project related assistance for all assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

Essential Functions

• Provide process and technical assistance to clinical trial site personnel and sponsor stakeholders regarding the use of technology that enables conduct of studies 
• Responsible for adding, updating and removing access to IQVIA technology solutions, or to studies utilizing the technology 
• Serve as liaison to study site personnel and IQVIA project teams to ensure, clarify or correct understanding of requirements for use of technology solutions
• Ensure accurate completion and maintenance of internal systems - electronic Clinical Outcome Assessments (“eCOA”), Interactive Response Technology (“IRT”), clinical trial management system ("CTMS"), etc. - databases, tracking tools, timelines and project plans with project specific information
• Tasks may be assigned on either start-up studies or maintenance studies
• Establish and maintain effective project/site communications
• Collaborate with project team members in creation/review/maintenance of study-specific process documents. Collaborate with product team members in creation of 
• Review, evaluate and recommend modifications to established or proposed processes
• Participate in study operational, as well as product and process improvement meetings and execute on related action items
• Coordinate with translation vendors and other in scope third-party services to deliver and operate clinical trials
• Respond to ad-hoc requests for study-related data, information and/or analysis
• Support participant study visits and generate appropriate reports and documents for research subjects prior to visits
• Suggest, initiate, recommend or provide clinically suitable and compliant actions and resolutions 

Qualifications

• 1-2 years of experience in clinical trials, related field or combination of education and experience
• Equivalent combination of education, training and experience
• Advance working knowledge of clinical system(s) and/or processes, applicable SOPs and regulations and understanding of system interactions/interdependencies.
• Effective problem-solving skills
• Effective communication and interpersonal skills
• Ability to establish and maintain effective working relationships with co-workers and managers