Associate Site Report Specialist

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

The Site Report Specialist (SRS) facilitates efficient and effective review of Site Visit Reports and to assure consistent standards of implementation for quality to meet or exceed quality standards, to ensure subject safety, data integrity, escalation of issues and timely and responsive

• Manage and oversee a caseload of visit report reviews for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA/applicable SOPs, and GCP guidelines, with support of SRS mentor or experienced SRS allocated to the same study.
• Leads comprehensive review of the visit reports to ensure all site issues are adequately documented, reported and followed up to resolution, as well as, assuring a high quality of SVRs.
• Supports providing training for CRAs on site visit report annotations and reports writing.
• Manage and oversee the project team compliance to SOPs for approval of the visit report through direct communication with the CRA and/or if necessary with Direct Line Manager (DLM).
• Document and escalate/communicate issues noted in the site visit report which could impact subject safety, regulatory compliance and/or data integrity to the CRA DLMs and study Protocol Team Lead(PTLs), as necessary.
• Review the visit reports to ensure documentation and implementation of e.g. audit or inspections, findings or focused site visit observations requiring corrective and /or preventative action plans.
• Attend regular teleconferences with PTL to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs in a given project. Assist the PTLs with review of the trends emerging from the Issue Escalation Log.
• Work with the project team members to decrease the level of corrections/additions needed on reports, provide continuous support to CRAs about reports’ writing requirements, providing ongoing mentoring, coaching and better understanding of the SVR annotations.
• Work with CRAs and study teams to support Open Action Items Management.

feedback in compliance with IQVIA SOP, ICH/ GCP guidelines, protocol requirements and regulatory compliance.

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