Udi Nir

Udi Nir Email and Phone Number

Clinical Study Manager @ ELGAN Pharma
Israel
Udi Nir's Location
Israel, Israel
Udi Nir's Contact Details

Udi Nir personal email

About Udi Nir

I’m a Clinical operation manager, with more then 15 years of experience looking for my next challenge

Udi Nir's Current Company Details
ELGAN Pharma

Elgan Pharma

View
Clinical Study Manager
Israel
Website:
elganpharma.com
Employees:
26
Udi Nir Work Experience Details
  • Elgan Pharma
    Elgan Pharma
    Israel
  • Pluristem Therapeutics
    Clinical Operations Manager
    Pluristem Therapeutics Dec 2021 - Jul 2023
    Haifa, Il
    Lead 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.
  • Pluristem Therapeutics
    Ctm
    Pluristem Therapeutics Oct 2019 - Dec 2021
    Haifa, Il
    Managing 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.
  • Novartis
    Clinical Study Manager
    Novartis Nov 2013 - Oct 2019
    Basel, Baselstadt, Ch
    Managing 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.
  • Novartis
    Cra
    Novartis Apr 2012 - Nov 2013
    Basel, Baselstadt, Ch
    Site management and monitoring according to Novartis global andlocal regulations, working together with central monitoring and risk- based monitoring, site staff training.
  • Gcp
    Cra
    Gcp 2010 - May 2012
    Il
    Site management and site monitoring site activities according to protocol, GCP, sponsor and internal regulations. Working with different sponsors. Site Training.
  • Sheba Medical Center
    Study Coordinator
    Sheba Medical Center 2008 - 2010
    Managing 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
  • Magen David Adom In Israel
    Paramedic
    Magen David Adom In Israel 2002 - 2007
    Il
    Paramedic, Head of Mobile Intensive Care unit

Udi Nir Skills

Clinical Trials Clinical Research Clinical Monitoring Protocol Ich Gcp Regulatory Submissions Gcp Edc Pharmaceutical Industry Patient Recruitment Cardiology Emergency Medicine Drug Development Clinical Development Oncology Infectious Diseases Sop Ctms Irb Crf Design Neurology Pharmaceutics Clinical Research Associates Life Sciences Site Management Multiple Sclerosis Project Management Management Training E Learning Computer Literacy Adverse Events Presentation Skills Cro Therapeutic Areas Clinical Data Management Regulatory Affairs

Udi Nir Education Details

  • University Of Haifa
    University Of Haifa
    Epidemiology
  • Pharma Job
    Pharma Job
    Ich-Gcp
  • Ben-Gurion University Of The Negev
    Ben-Gurion University Of The Negev
    Emergency 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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