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.
Maintenance Analyst is responsible for coordination of global implementation of core documents amendments with countries, ensuring documentation of submission/approval process in CTMS, filing compliance in eTMF. Revenue for this position is generated via CO additional budget reimbursed by a client to cover amendment activities.Maintenance Analyst Job Responsibilities (Regulatory & Start Up Department for projects conducted globally):To coordinate the submission & approval process of revised clinical study documents at Maintenance Phase for assigned projects in accordance with the agreed Regulatory and Start Up strategy.To ensure collaboration across Regulatory and Start-Up team, including communication with countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.To assist with creation and/or review of technical and administrative documentation to enable study regulatory maintenanceTo Assist the team in the preparation, handling, distribution, filing and archiving of documentation according to the scope of work and standard operating proceduresTo review documents for completeness, consistency and accuracy, under guidance of senior staffTo provide overall guidance and oversight of multi-site & multi-country projects during regulatory maintenance phaseTo adhere to regulatory strategy/expectations and parameters for submissions and all necessary authorizationsTo ensure appropriate quality standards (following RSU Management Plan and relevant Work Instructions) for the duration of Regulatory Maintenance phase.To assist with accurate completion and maintenance of internal systems (with emphasis on Clinical Trial Management Systems & Trial Master Files), databases, tracking tools, timelines and project plans with project specific information.To contact country teams for specific requests (e.g., updates on submissions/approvals, missing tracking in systems, missing documentation, etc.).To co-ordinate document translation.To attend project team and local meetingsTo be familiar with ICH GCP, appropriate regulations, relevant SOPs & internal trackin+C42g systems.Prepare client deliverable documents using appropriate tools and draft text for straightforward documents, under guidance of senior staffTo assist in the production of reports slides, overheads, etc., as needed for project, departmental, s+C18ponsor and/or business development presentations.Provide support for administrative tasks, e.g. meeting coordination, minute taking, travel arrangements, faxing, copying, couriersOther duties as assigned
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Job ID: R1092368
