Experienced Clinical Research Associate, IQVIA Biotech
3 giorni fa
Job Overview: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions: • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Collaborate and liaise with study team members for project execution support as appropriate.• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications University Bachelor's Degree and Master's Degree in scientific discipline or health care In possession of CRA Certification as required by Ministerial Decree dated Experience in Pharma Industry, and/or Clinical Trials environment Very good computer skills including MS Office Excellent command of English language Organizational, time management and problem-solving skills Ability to establish and maintain effective working relationships with coworkers, managers, and clients Flexibility to travel Driver’s license class B 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
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Clinical Research Associate, Sponsor Dedicated
1 settimana fa
Milan, Italia IQVIA A tempo pienoExperienced Clinical Research Associate, Italy Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits Supporting the development of a subject recruitment plan Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International...
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Clinical Research Associate, Site Management
2 settimane fa
Milan, Italia IQVIA A tempo pienoJob Overview Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. Essential Functions • Complete appropriate therapeutic, protocol and clinical research...
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Clinical Research Associate
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Milan, Italia ICON A tempo pienoCRA II / Senior CRA ICON Biotech ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate...
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Clinical Vendor Manager
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Milan, Italy (ITALY, ) IQVIA A tempo pienoOn behalf of our Client a global pharmaceutical company, IQVIA is looking for Vendor Management Lead, Drug Development.The profile will be responsible for selection, contracting, oversight, and performance management of external vendors and collaborators based in Italy, supporting clinical development. External vendors include CROs, CMOs, central labs and...
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Global Clinical Project Manager
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Milan, Italia IQVIA A tempo pieno*Please note that, due to specific sponsor's requests, we can only consider candidates with minimum one year of prior Global LEAD experience and coming from the locations where the job advertisement is posted. Applications from other locations will not be considered.* Job Overview Project Leads are an integral part of clinical trial delivery, liaising with...
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Informatore Scientifico del Farmaco
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Milan, Italia Altro A tempo pienoOverviewThe Associate Medical Director will provide medical, clinical and scientific advisory expertise to all IQVIA divisions as requested. Participate in all aspects of Medical Science involvement on assigned trials. Serve as a medical expert during the project delivery lifecycle. Provide therapeutic and medical expertise to business development...
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Senior Clinical Research Associate
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Associate Market Access Specialist, North Italy
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Milan, Italia IQVIA A tempo pienoEvery 30 minutes, a stroke patient who could have been saved either dies or is permanently disabled because they were treated in the wrong hospital. Our mission is clear: to increase the number of patients treated in stroke-ready hospitals and to optimize the quality of treatment in all existing stroke centers. We are building a global community of stroke...
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Milan, Italia IQVIA A tempo pienoPurpose The Associate Director, Translations Project Management and Content Design plays a strategic role in driving customer engagement across APAC markets and providing leadership for global teams involved in language services and content design. This position is pivotal in building and maintaining strong relationships with Asian customers, ensuring their...
