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Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to Project Manager, Head of Clinical Operations or Senior Management, if needed. Leading CRO contracts negotiations together with the argenx vendor manager.
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The clinical study manager is responsible for all operational aspects of the assigned clinical studies from initiation till closure of the studies. ICON plc is a world-leading healthcare intelligence and clinical research organization.
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Ensuring that study Trial Master File is maintained and up to date. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being.
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Bachelors degree or University degree medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation.
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Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study. Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of MedWatch reports to FDA, EMEA and other applicable regulatory authorities.
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Providing input into and/or developing study related materials such as Clinical Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms etc.
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The CSM will be the operational clinical study voice for the assigned studies, both internally and externally, he or she is owning the timelines of a clinical study project and is accountable to keep the study on track.
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At ICON, diversity, inclusion & belonging are fundamental to our culture and values. The successful candidate will have clinical study operational experience in phase I, II and III drug development phases and is an operational expert in the clinical study activities from start-up, execution until closure and its underlying activities.
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Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations. Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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The CSM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure. Responsible for risk management of the assigned studies: performing (pre-)study risk assessment and ensuring that mitigation steps for potential risks are taken.
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Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns. Were 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.
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Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained. Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan.
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Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Auto-immune and/or oncology clinical study background is a plus. Responsible and contact person during inspections/audits for the assigned studies together with the Quality Assurance representative.
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Establishing and maintaining good relation with clinical site and study personnel. Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan.
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Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent. Leading and guiding the internal clinical study team and chairing study team meetings. Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals.
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Title: senior manager Company: Icon Clinical Research
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