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Clinical Solutions Consultant
2 months ago
Position Overview
The Clinical Solutions Consultant will become a Subject Matter Expert in the field of Medical Devices and the role of our eSource Platform in clinical trials, providing essential support to sites and sponsors. The primary focus will be on the deployment and continuous assistance of Devices allocated to sites throughout all stages of clinical trials. You will work closely with project managers, engineers, product managers, business analysts, documentation specialists, scientists, medical professionals, technologists, IT experts, and computer systems validation specialists utilizing Service Desk and other project tools to advise and support both new and existing sponsors and sites. This role demands strong analytical capabilities, meticulous attention to detail, and an understanding of clinical operations to effectively train, coach, and assist customers in utilizing Medical Devices and our eSource/eCRF/EDC tool in clinical trials. You will guide them on efficient workflows for trial preparation, execution, oversight, and data export collected during their clinical trials. The Senior Clinical Solutions Consultant will collaborate within global multi-functional internal and external project teams.Key Responsibilities
Develop expertise in Medical Devices and eSource/eCRF (ClinSpark) functions in clinical trial operations and management. Review and address site and customer support inquiries from Service Desk and other project/support tools regarding devices and the eSource platform. Assist in documenting Medical Devices and ClinSpark interactions for ongoing customer support, including user guides based on components and roles. Occasionally contribute to the creation of specifications for new reports and dashboard visualizations. Provide usability insights and solutions for internal teams and external clients to resolve issues and enhance efficiency. Meet assigned milestones and collaborate with the support team to organize timelines, responsibilities, and deliverables. Foster and maintain effective communication and working relationships with internal teams and external clients.Required Qualifications
Experience in Medical Devices, clinical operations, laboratory operations, or data management within early-phase clinical trials, such as in a Clinical Pharmacology Unit or Contract Research Organization. Familiarity with clinical trial management software (eSource, eCRF, EDC) in a clinical trial environment. Background as a study designer for clinical trial automation and/or eSource software and/or Electronic Data Capture (EDC) systems. Knowledge of relevant clinical research, regulatory, and other requirements, including Good Clinical Practice, HIPAA, and GDPR. Strong communication and presentation skills, with a good command of the English language. Excellent customer management abilities and a proven track record of understanding customer needs, navigating difficult conversations with stakeholders, negotiating solutions, and recognizing the impacts of proposed solutions on overall projects. Proficient software and computer skills. Understanding of HL7, CDISC ODM, CDASH, SDTM, and related standards. Experience in Phase I-IV clinical trial operations. Familiarity with the use of medical devices and computer hardware in clinical trials. Experience in creating documentation for ongoing support of clinical trial operations. Experience in developing documentation for software usability in a clinical trial context. Experience in training end users on software usage in a clinical trial setting. Knowledge of operating procedures and work instructions, with the ability to apply them effectively. Proven time management and problem resolution skills. Demonstrated creative problem-solving abilities. Strong organizational, communication, and collaboration skills. Ability to establish and maintain effective working relationships with colleagues, managers, and clients. Proven capability in managing clinical trial support.IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are dedicated to pushing the boundaries of human science and data science to create a significant impact – helping our customers foster a healthier world.
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 that IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.
The potential base pay range for this role, when annualized, is $71,000 to $118,000. The actual base pay offered may vary based on various factors, including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be provided, in addition to a range of health and welfare and/or other benefits.
