Clinical Solutions Consultant

1 week ago

San Francisco, California, United States IQVIA Full time

Position Summary

The Clinical Solutions Consultant will develop expertise in the area of Medical Devices and the role of our eSource Platform in clinical research, offering support to both sites and sponsors. This role emphasizes the deployment and continuous assistance of Devices allocated to sites throughout all stages of clinical trials. Collaboration with project managers, engineers, product managers, business analysts, documentation specialists, scientists, medical professionals, technologists, IT experts, and computer systems validation specialists will be essential, utilizing Service Desk and other project tools to provide guidance and support to sponsors and sites. Strong analytical abilities, meticulous attention to detail, and a solid understanding of clinical operations are necessary to train, mentor, and assist clients in utilizing Medical Devices and our eSource/eCRF/EDC tools during clinical trials. You will offer guidance on effective workflows for trial preparation, execution, oversight, and data export. The Clinical Solutions Consultant will engage with global, multi-functional internal and external project teams.

Key Responsibilities

Attain Subject Matter Expertise in Medical Devices and eSource/eCRF (ClinSpark) roles within clinical trial operations and management. Address and manage site and customer support inquiries through Service Desk and other project/support tools related to devices and the eSource platform. Aid in the documentation of 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 recommendations and solutions for internal teams and external clients to resolve issues and enhance efficiency. Meet assigned milestones and collaborate with the support team to coordinate timelines, responsibilities, and deliverables. Foster effective communication and relationships with internal teams and external clients.

Required Qualifications

Proven experience in Medical Devices, clinical operations, laboratory operations, or data management within early-phase clinical trials, such as 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. Understanding of relevant clinical research, regulatory, and other requirements, including Good Clinical Practice, HIPAA, and GDPR. Exceptional communication and presentation skills, with a strong command of the English language. Proven customer management abilities and the capacity to comprehend customer needs, engage in challenging discussions with stakeholders, negotiate solutions, and assess the implications of proposed solutions on overall projects. Strong software and computer proficiency. Knowledge 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 clinical trial operations support. Experience in developing documentation for software usability in a clinical trial context. Experience in training end users on software utilization in a clinical trial setting. Knowledge of operational procedures and work instructions, with the ability to apply them effectively. Proven time management and problem-solving skills. Demonstrated creative problem-solving capabilities. Strong organizational, communication, and collaboration skills. Ability to establish and maintain effective working relationships with colleagues, managers, and clients. Demonstrated capability in managing clinical trial support.

IQVIA is a premier global provider of advanced analytics, technology solutions, and clinical research services to the life sciences sector. We are dedicated to pushing the limits of human science and data science to create significant impacts, aiding our clients in fostering a healthier world.

We are committed to ensuring equal employment opportunities for all, including veterans and candidates with disabilities.

IQVIA's ability to operate and provide specific services to clients and partners requires that IQVIA and its employees meet certain COVID-19 vaccination status requirements.

The potential base pay range for this role, when annualized, is $71,000 to $118,000. Actual base pay 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, incentive plans, bonuses, and/or other forms of compensation may be offered, along with a range of health and welfare benefits.

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