Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Develops project plan with timelines and deliverables and leads project to successful completion, on-time and on-budget, from start to finish with limited senior management guidance.
Recommends improvements and alternative solutions to resolve problems.
Develops project plan with timelines and deliverables and leads project to successful completion, on-time and on-budget, from start to finish with limited senior management guidance.
Recommends improvements and alternative solutions to resolve problems.
Review, prepare and negotiate site contracts and budgets with sites, if applicable.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
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Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. You will need to have a good knowledge of applicable clinical research regulatory requirements.
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Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. You will need to have a good knowledge of applicable clinical research regulatory requirements.
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Actively contribute to innovation initiatives, including the evaluation of emerging technologies, process automation, and intelligent workflows within laboratory operations.
Challenge existing processes by proposing modern, scalable, and technology‑driven alternatives to traditional project set‑up models.
Lead or contribute to lessons‑learned sessions, translating insights into actionable recommendations and innovation roadmaps.
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Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
May support People Manager with the oversight of their staff, to ensure quality deliverables.
May identify quality risks and issues and support with the creation of appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
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Actively contribute to innovation initiatives, including the evaluation of emerging technologies, process automation, and intelligent workflows within laboratory operations.
Challenge existing processes by proposing modern, scalable, and technology‑driven alternatives to traditional project set‑up models.
Lead or contribute to lessons‑learned sessions, translating insights into actionable recommendations and innovation roadmaps.
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Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
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