Summary
Overview
Work History
Education
Skills
Humanitarian Experience
Job Titles
Country Of Residence
Languages
Clinical Trial Experience
References
Timeline
Generic
Nagham Sleiman

Nagham Sleiman

Berlin

Summary

Dynamic Site Management Associate at ICON with expertise in clinical trial management and regulatory submissions. Proven ability to enhance operational efficiency and ensure compliance with GCP standards. Strong communicator with a focus on aligning team goals and objectives for optimal results. enhancing overall study outcomes.

Overview

19
19
years of professional experience

Work History

Site Management Associate

ICON
Berlin
02.2022 - Current
  • Managing clinical trials on the behalf of the sponsors in Germany, Austria and Switzerland.
  • Primary site contact: perform site management and monitoring activities, remote monitoring, document collection and review, TMF reviews, assess site performance, and escalate if needed.
  • Collected, reviewed, and filed essential documents in compliance with the ICH-GCP guidelines.
  • Ensured timely submission and approval of site regulatory documents by closely monitoring and recording them in CTMS.
    • Conducted numerous TMF reviews, including those done post site closure.
    • Trained personnel on new protocol changes, company monitoring model, and study specifics.
    • Worked jointly with colleagues and sponsor to reach multiple database locks and secure FDA approval for one IP.
    • Executed assigned duties autonomously by adhering to the company's or sponsor's SOPs and study plan documents.
  • Managed routine tasks efficiently while handling inquiries from site personnel, IRB/IEC, and sponsors.
    Experience in diverse study fields, including oncology, Hematology, Dermatology and immunology.
  • Working in the clinical delivery team, ensuring the study is run according to protocols, SOPs, and GCP standards.
  • In Nov 2024, I have successfully completed the CRA/Clinical Research Associate Bridge Program.

Study Nurse

Cardiology Study Center - Charite
Berlin
09.2021 - 01.2022
  • Phase 3 - Main contact with national and International Sponsors.
  • The Studies are focused on cardiac diseases, Following different Protocols and agreed SOP's.
  • Conducting on-site patient visits, remote patient visits, and follow-up visits.
  • Entering data, solving queries, and working with different report systems.

Clinical Research Nurse

PAREXEL International GmbH
Berlin
08.2020 - 07.2021
  • Company Overview: Berlin, Germany
  • Early Phase Clinical Unit.
  • Preparation and performance of Phase I - IIa studies.
  • Berlin, Germany

Nurse in Intermediate Intensive Care

Vivantes Neukölln
Berlin
01.2019 - 12.2020
  • Company Overview: Berlin, Germany
  • Working intensively with close treatment with patients, main diseases: Chirurgy, post chirurgical operations, post orthopedic operation, lung disease, cardiology and Trauma.
  • Responsibilities included, medical treatment, advanced medical first aid treatment, neurological, mental, hemodynamic, respiratory monitoring, wound healing, drug preparations and submission.
  • Admission and discharge of patients.
  • Berlin, Germany

Specialized Nurse in General Intensive Care

Assuta Hospital
Tel-Aviv
01.2016 - 12.2018
  • Company Overview: Tel-Aviv, Israel
  • Tasks included collecting case data, case management, treatment, follow ups, bedside procedures including intubation, ventilation and extubation, monitoring & assessing patients' state of health and training of new nurses.
  • Tel-Aviv, Israel

Specialized Nurse in Cardiology Intensive Care

Sourasky Medical Centre
Tel-Aviv
01.2009 - 12.2012
  • Company Overview: Tel-Aviv, Israel
  • Tasks included intensive care (one nurse per 1-2 patient(s) per shift), life critical decision making and psychological support.
  • Monitoring & assessing patients' state of health, treatment, drugs distribution and management.
  • Training of new nurses to the unit.
  • Tel-Aviv, Israel

Nurse in Emergency Room

Sourasky Medical Centre
Tel-Aviv
01.2006 - 12.2008
  • Company Overview: Tel-Aviv, Israel
  • Tasks included working within all disciplines such as orthopedics, surgery, trauma, intern medicine and cardiology.
  • I was responsible for TRIAGE, collecting case data, case management, treatment, follow ups, bedside procedures, monitoring & assessing patients' state of health and training of new nurses.
  • Tel-Aviv, Israel

Education

Certificate - CRA (Clinical Research Associate) Bridge Program

ICON
Germany
11-2024

Master of Arts - Gender studies

Tel-Aviv University
Israel
01.2013

Masters in Art - Gender studies

Monash university
Melbourne, Australia
01.2011

Specialisation in critical care and emergency medicine - Nursing

Tel-Aviv Academic Nursing school
Israel
01.2008

Bachelor in Nursing - Nursing

Tel-Aviv University
Israel
01.2006

Skills

  • Clinical trial management
  • Regulatory submissions
  • Document management
  • Site monitoring
  • Team collaboration
  • Patient care
  • Problem solving
  • Risk assessment
  • Attention to detail
  • Time management
  • Effective communication
  • Training coordination
  • Self-Organization

Software

Microsoft Office

Various CTMS programs

Various eTMF programs

Languages

English

German

Hebrew

Arabic - native

Humanitarian Experience

  • 2015-2016, Finnish Red Cross, Helsinki, Finland, Event and Integration Coordinator, Integration support for refugees., Worked closely with refugees centers to provide integration facilities mainly for women and families., The integration support included event and activities planning, translation services frontal and written, accompanied for official appointments and more.
  • 2015-2016, Finnish Refugee Council, Helsinki, Finland, Event and Integration Coordinator, Integration support for refugees., Worked closely with refugees centers to provide integration facilities mainly for women and families., The integration support included event and activities planning, translation services frontal and written, accompanied for official appointments and more.
  • 2016, Oltumo Project, Kenya, Health Care Educator and Cultural Bridger, Volunteering in a small permaculture project in southern Kenya., The project is aimed to provide different basic education and support to the Massai community., The main focus is agriculture education, modern technologies education such as solar powers and health education such as prevention medicine and awareness.
  • 2014, Small Hostel, Eua, Tonga, Hospitality Helper, Volunteering in a small hostel., Mainly introducing the locals to different ways and platforms for strengthening their business and kitchen work.
  • 2014, Maylon House, Mount Manganui, New Zealand, Caregiver, Part of a team consisting of 25 staff members., Tasks included daily care of residents and alertness for change in their condition., The care included physical, psychological and holistic care to maintain resident life quality.
  • 2010, Breaking the Barriers Project, Germany, Arabic-Hebrew-English Oral Translator, Simultaneous oral translations during seminars between three groups of Palestinians, Israelis and Germans., Managing and organizing the seminar activities and the participants.

Job Titles

  • Site Management Associate
  • Clinical Research Nurse
  • Intensive Care Registered Nurse
  • Emergency Care Registered Nurse

Country Of Residence

Germany

Languages

  • Arabic, Fluent, Fluent, Fluent
  • Hebrew, Fluent, Fluent, Fluent
  • English, Fluent, Fluent, Fluent
  • German, Business Level, Fluent, Business Level
  • Finnish, Basic Level, Basic Level, Basic Level

Clinical Trial Experience

  • Phase 3, Oncology, Endometrial, Medidata Rave/Veeva Vault
  • Phase 3, Oncology, NSCLC, Medidata Rave/Phlex
  • Phase 3, Oncology, Pancreatic, Medidata Rave/Sponsor TMF
  • Phase 2, Oncology, NSCLC, Medidata Rave/Veeva Vault
  • Phase 1, Hematology, Multi Hematologic Malignancies, Medidata Rave/Sponsor TMF
  • Phase 2, Immunology, Crohn's Disease, Medidata Rave/Veeva Vault
  • Phase 2, Oncology, Colorectal, Medidata Rave/Phlex
  • Phase 3, Dermatology, Atopic Dermatitis, Medidata Rave/Phlex

References

References available upon request.

Timeline

Site Management Associate

ICON
02.2022 - Current

Study Nurse

Cardiology Study Center - Charite
09.2021 - 01.2022

Clinical Research Nurse

PAREXEL International GmbH
08.2020 - 07.2021

Nurse in Intermediate Intensive Care

Vivantes Neukölln
01.2019 - 12.2020

Specialized Nurse in General Intensive Care

Assuta Hospital
01.2016 - 12.2018

Specialized Nurse in Cardiology Intensive Care

Sourasky Medical Centre
01.2009 - 12.2012

Nurse in Emergency Room

Sourasky Medical Centre
01.2006 - 12.2008

Certificate - CRA (Clinical Research Associate) Bridge Program

ICON

Master of Arts - Gender studies

Tel-Aviv University

Masters in Art - Gender studies

Monash university

Specialisation in critical care and emergency medicine - Nursing

Tel-Aviv Academic Nursing school

Bachelor in Nursing - Nursing

Tel-Aviv University
Nagham Sleiman