Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Specific responsibilities may vary across individual positions. Typical responsibilities of this job classification include the following:
·Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.
·Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
·Review and provide feedback to management on site performance metrics.
·Serve as contact for investigative sites, designated project reports, communications, and customer service.
·Resolve site issues and determine status for product shipment.
·Work with regulatory team members or sponsor to secure authorization of regulatory documents.
·Work with legal team members or sponsor to secure authorization of contracts.
·Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
·Inform team members of completion of regulatory and contractual documents for individual sites.
·Work with team members in preparation of regulatory submissions per work instructions.
·May serve as a SSU Team Lead for country or region as needed. Coordinate activities for projects within area of specialization.
·May translate or review completed translations of critical documents.
·May participate in feasibility and/or site identification activities.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
·In-depth knowledge of clinical systems, procedures, and corporate standards
·Strong knowledge of medical terminology and regulations
·Broad knowledge of clinical research
·Strong knowledge of Microsoft Office and e-mail applications
·Effective communication, organizational, and interpersonal skills
·Ability to work independently and to effectively prioritize tasks
·Ability to manage multiple projects
·Attention to detail
·Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
·Bachelor’s Degree in a related field and 1 year clinical research experience; or equivalent combination of education, training and experience
·Extensive use of telephone and face-to-face communication requiring accurate perception of speech
·Extensive use of keyboard requiring repetitive motion of fingers
·Regular sitting for extended periods of time
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™