Job Overview The Solution Specialist will ultimately become a Subject Matter Expert in the domain of Medical Devices and our eSource Platform’ s role in clinical trials; providing customer support to site and Sponsors. The focus will be on the implementation and ongoing support of Devices that are provisioned to site supporting all phases of clinical trials. You will collaborate with project managers, engineers, product managers, business analysts, documentation specialists, scientists, medical experts, technologists, IT professionals and computer systems validation specialists using Service Desk and other project tooling, in order to advise and support new and existing sponsors and sites. The role requires strong analytical skills, attention to detail, combined with clinical operations awareness, in order to train, coach and assist customers in their use of Medical Devices and our eSource/eCRF/EDC tool in clinical trials. You will advise and support them on effective workflows for the preparation of a trial, and the conduct, oversight, and export of data collected in their clinical trials. The Senior Solution Specialist will be required to work within global multi-functional internal and external project teams. Essential Functions Become a Subject Matter Expert in the domain of Medical devices and eSource/eCRF (ClinSpark) roles in clinical trial operations and management Review and respond to site and customer support requests from Service Desk and other project/support tooling on devices and eSource platform Assist with documentation of Medical devices and ClinSpark interactions for ongoing customer support, including component-based and role based user guides Occasionally assist with specification creation for the development of new reports and dashboard visualizations Provide usability advice and solutions for internal teams and external customers to solve problems and improve efficiency Meet milestones as assigned, and interact with the support team to organize timelines, responsibilities and deliverables. Develop and maintain good communications and working relationships with internal teams and external clients. Qualifications * Experience working in Medical Devices, clinical operations, laboratory operations or data management in early phase clinical trials such as a Clinical Pharmacology Unit or Contract Research Organization Experience working with clinical trial management software (eSource, eCRF, EDC) in a clinical trial setting Experience as a study designer for clinical trial automation and/or eSource software and/or Electronic Data Capture (EDC) systems Knowledge of applicable clinical research, regulatory and other requirements; i.e., Good Clinical Practice, HIPAA, GDPR Excellent communication and presentation skills, including good command of English language Excellent customer management skills and demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions, and understand impacts of proposed solutions on the overall project Strong software and computer skills Knowledge of HL7, CDISC ODM, CDASH, SDTM and related standards Experience in Phase I-IV clinical trial operations Experience with the use of medical devices and computer hardware in clinical trials Experience creating documentation for ongoing support of clinical trial operations Experience creating documentation for software usability in a clinical trial setting Experience training end users on the use of software in a clinical trial setting Knowledge of operating procedures and work instructions and the ability to apply them in practice Previous experience and proven competence with time management and problem resolution skills Demonstrated experience with creative problem solving Demonstrated organizational, communication, and collaboration skills Ability to establish and maintain effective working relationships with coworkers, managers and clients Demonstrated ability to manage clinical trial support IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. The potential base pay range for this role, when annualized, is $71,300.00 – $118,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. #J-18808-Ljbffr
Coaching Assistant Business Analyst Analytical skills Problem-solving Operational activities cdash time-management hl7 data-collections Documentation creation Support Specialist Communication Collaboration Information technology (IT) Training usability Relationship Management implementation Engineering Project management Organizational skills Help Desk Product management