Udi Nir work email
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Udi Nir personal email
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I’m a Clinical operation manager, with more then 15 years of experience looking for my next challenge
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Elgan PharmaIsrael -
Clinical Operations ManagerPluristem Therapeutics Dec 2021 - Jul 2023Haifa, IlLead and align global clinical operations team and projects in EU, USA and ISR (timelines, cost, quality). Direct management and team leading of cross-functional teams (CTM’s, CRA’s, CTA’ etc.). Planning and oversight of all studies goals, timelines, and plans (protocol, recruiting, monitoring etc.) Finance forecasting for department and study specific, department budget management. Prioritizing workload and resources for the clinical operations unit, risk-based in order to identify and mitigate potential issues. Working closely with finance, safety, data, and legal departments. CRO and vendor selection and oversight (monitoring, data review, labs and more), contracts, and budget negotiations. SOP writing, responsible for training programs and quality. -
CtmPluristem Therapeutics Oct 2019 - Dec 2021Haifa, IlManaging all aspects of international phase I, II and III cell therapy studies in various therapeutic areas (wound, COV-19, orthopedic surgery, hematology). Managing studies according to project milestones in multiple countries and sites (EU, USA, and Israel) CRO’s management, managing CRA’s, CTM’s and PM’s, decision making, problem solving and conflict resolution for managed studies. Study finance management, budget planning and execution. IP supply oversight. External committees and other vendors management and coordination. CRA and site staff training, managing Interim and Primary Analyze. CSR finalization and submission. -
Clinical Study ManagerNovartis Nov 2013 - Oct 2019Basel, Baselstadt, ChManaging all aspects of global studies in selected therapeutic fields (cardiology, dermatology, oncology, neurology, ophthalmology etc.) from start-up to close out, budget, finance and contract, site selection, CRA and site training, in charge of CRA's, SOP's writing, E-System super user. -
CraNovartis Apr 2012 - Nov 2013Basel, Baselstadt, ChSite management and monitoring according to Novartis global andlocal regulations, working together with central monitoring and risk- based monitoring, site staff training. -
CraGcp 2010 - May 2012IlSite management and site monitoring site activities according to protocol, GCP, sponsor and internal regulations. Working with different sponsors. Site Training. -
Study CoordinatorSheba Medical Center 2008 - 2010Managing and coordinating all aspects of clinical trials Working with pharmaceutical companies and CRO's in Israel and abroad Preparing all submissions to the IEC, writing ICF's, protocols and CRF's
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ParamedicMagen David Adom In Israel 2002 - 2007IlParamedic, Head of Mobile Intensive Care unit
Udi Nir Skills
Udi Nir Education Details
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University Of HaifaEpidemiology -
Pharma JobIch-Gcp -
Ben-Gurion University Of The NegevEmergency Medical Technology/Technician (Emt Paramedic)
Frequently Asked Questions about Udi Nir
What company does Udi Nir work for?
Udi Nir works for Elgan Pharma
What is Udi Nir's role at the current company?
Udi Nir's current role is Clinical Study Manager.
What is Udi Nir's email address?
Udi Nir's email address is ni****@****ail.com
What schools did Udi Nir attend?
Udi Nir attended University Of Haifa, Pharma Job, Ben-Gurion University Of The Negev.
What skills is Udi Nir known for?
Udi Nir has skills like Clinical Trials, Clinical Research, Clinical Monitoring, Protocol, Ich Gcp, Regulatory Submissions, Gcp, Edc, Pharmaceutical Industry, Patient Recruitment, Cardiology, Emergency Medicine.
Who are Udi Nir's colleagues?
Udi Nir's colleagues are Dmitry Miskevich, Donna Donin Ehrenberg, Valeria Rukhman, Itamar Ben Tzoref, Genya Mor, Makenzee Curtis, Olga Belotserkovsky.
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