Orit Zimerman

Orit Zimerman Email and Phone Number

Clinical Trial Manager @ AMORPHICAL
Israel
Orit Zimerman's Location
Nes Ziona, Center District, Israel, Israel
Orit Zimerman's Contact Details

Orit Zimerman work email

Orit Zimerman personal email

About Orit Zimerman

Project manager and Lead Clinical Research Associate with 15 years of experience in clinical trials.Significant experience in Clinical trials phases II-IV in both adult and pediatric population. Performed and Management all aspects of the clinical monitoring process-study start-up, initiation, interim and close out activities; to ensure applicable timelines and metrics are met, including all regulatory, legal and financial aspects in accordance with FDA, ICH-GCP guidelines and global SOP; prioritize subject safety, data integrity and timeline management. Experienced Optometry Specialist with strong healthcare services professional with a Bachelor of Science - BSc focused in Optometry from Bar-Ilan University and an MBA Bio - Medical Management from the Collage of Management.I am interested in taking the next step and continuing my progression toward greater success and accomplishment in the industry.

Orit Zimerman's Current Company Details
AMORPHICAL

Amorphical

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Clinical Trial Manager
Israel
Orit Zimerman Work Experience Details
  • Amorphical
    Clinical Trial Manager
    Amorphical
    Israel
  • Enlivex Therapeutics (Nasdaq: Enlv)
    Pm & Lcra
    Enlivex Therapeutics (Nasdaq: Enlv) Mar 2022 - Oct 2023
    Israel
    As Project manager Management 2 studies concurrently in following indication: Organ failure associate with Covid 19 & Leukoparesis studyResponsibilities:• Developing a comprehensive understanding of study objectives, design, regulatory requirements, timelines, risks/benefits for each project.• Coordinating and Collaborating with external vendors (e.g., CRO’s, Core labs) as well as internal departments (e.g., Regulatory Affairs, finance, quality assurance, manufacturing).• Tracking all patient recruitment and treatments within CTMS; work with sites and monitors to address all site compliance issues, data issues, and safety issues; elevate issues as needed to Clinical Affairs management.• Overseeing all sites are current with data entry and conducting routine data reviews to ensure the quality of data.• Performing and documenting study site training • Safety management• Budget / payments, overseeing all project goals are met per timeline and budget• Creating and reviewing study protocol, Inform consent, monitoring plan and other study documentsNov 2022 until Oct 2023: Lead CRA Study indication Organ failure associate with Sepsis and Advanced Solid Tumor Malignancy Responsibilities:• Leading team of 3 CRAs and 2 CTAs including training, co- monitoring, acting as the first line of contact for study specific issues and questions and confirm their implementation• Performing QA assessment visit and co- monitoring visits at ISR & EU- sites• Supporting PM, in overseeing clinical monitoring and operational study execution of assigned protocol • Reviewing CRAs trip reports in ISR & EU- sites.• Full responsibility for local conference including administration and content.• Overseeing required regulatory applications/ submissions for EC and MOH.
  • Enlivex Therapeutics (Nasdaq: Enlv)
    Senior Cra
    Enlivex Therapeutics (Nasdaq: Enlv) Jan 2021 - Nov 2022
    Israel
    As CRA responsible for the Study indication Organ failure associate with Sepsis and Covid 19Performing 100% or reduced SDV, on-site and remote visits, familiar with AIM methodology and Risk Based Monitoring.Creating required regulatory applications/ submissions for EC and MOH.Site management support
  • Ppd
    Senior Cra
    Ppd Jan 2019 - Jan 2020
    Management 3 studies concurrently in following indications:• Pediatric epilepsy: in 7 neurological departments• Metochromatic leukodystrophy MLD – in Ichilov neurology department• Ophthalmology: Wet AMD: In 8 ophthalmology departments
  • Icon Plc
    Cra
    Icon Plc Aug 2008 - Jan 2019
    2015 – 2018 CRA II: Clinical Research AssociateAwards: Granted four awards from Clinical Trial Managers due to high performers. Management the following major studies in the following indications:• Cardiology: Prevention of cardiovascular disease, hypercholesterolemia - in cardiology and internal medicine departments• Musculoskeletal: Fractures of the hip - in orthopedic departments• Vascular: Critical Ischemia in the Limbs - Vascular Clinics2008 - 2015 CTA: Senior Clinical Trial Assistant & LCTA Lead Clinical Trial AssistantThe following responsibilities were included with this position:• Responsible for the EU/ISR region• Tracking study-¬specific status reports to ensure all required information regarding site issues, deviations, and CRF status were kept current by the monitoring team• Setting up, organizing and maintaining clinical study documentation (e.g. Main Study Files, CRFs, etc.) Including preparation for internal/external audits, final reconciliation and archival• Co-coordinating ordering and tracking of trial materials (e.g. CRFs, lab supplies, drug supplies) • Attending project team meetings and generate meeting minutes• Preparing and submitting required regulatory applications for local EC and MOH.• Supporting with collecting critical documents until site activation approval is received
  • Optometry Store
    Optometrist
    Optometry Store 2001 - 2007
    Tel Aviv, Israel
    Optometrist• Performing optometric examination: refraction and orthoptic diagnosis, detection and diagnosis of various eye diseases, prescribe spectacles and contact lenses.• Providing special treatments, such as vision therapy and low-vision rehabilitation.

Orit Zimerman Skills

Clinical Development Medical Devices Biotechnology Lifesciences Pharmaceutical Industry Clinical Trials

Orit Zimerman Education Details

Frequently Asked Questions about Orit Zimerman

What company does Orit Zimerman work for?

Orit Zimerman works for Amorphical

What is Orit Zimerman's role at the current company?

Orit Zimerman's current role is Clinical Trial Manager.

What is Orit Zimerman's email address?

Orit Zimerman's email address is or****@****plc.com

What schools did Orit Zimerman attend?

Orit Zimerman attended The College Of Management Academic Studies, Bar-Ilan University.

What skills is Orit Zimerman known for?

Orit Zimerman has skills like Clinical Development, Medical Devices, Biotechnology, Lifesciences, Pharmaceutical Industry, Clinical Trials.

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