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Head of ECOA Study Operations

IQVIA Holdings Inc.

Various Locations

Opportunity to join a growing project in our company, Sofia, Bulgaria, Remote based

Job Overview:

Perform a variety of administrative tasks in support of clinical trials and assist in the performance of 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 a wide range of process and 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.

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 technology solutions, or to studies utilizing the technology 
• Serve as liaison to study site personnel and IQVIA project team to ensure, clarify or correct misunderstanding of requirements for technology solutions
• Provide 1st and 2nd level process support, and 2nd level technical support, for clinical trials technology systems
• Input visit activity data into required systems - electronic Clinical Outcome Assessments (“eCOA”), Interactive Response Technology (“IRT”), clinical trial management system ("CTMS"), etc. - to track patient visits and procedures completed against the study budget
• 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 resolutions as appropriate
• Adheres to all relevant associated SOPs/Work Instruction and other guidelines
• 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, removing, updating access to technology and/or to the studies utilizing the technology 
• Collect and submit regulatory/ethics documentation pertaining to the research study.

Qualifications
• Relevant degree in health or biological science and related studies
• Requires 1-2 years of prior relevant experience in a clinical research environment with specific knowledge of clinical trials systems
• 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

• If you're not a EU citizen you must have a resident visa or a permanent visa.

#LI-VC2

#LI-REMOTE

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

Job posted: 2021-05-05

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