Summary
Overview
Work History
Education
Skills
Additional Information
Accomplishments
Certification
Interests
Timeline
Hi, I’m

Ahmed Osama Massoud

Senior Clinical Resrrach Associate
Cairo
Ahmed Osama Massoud

Summary

A n enthusiastic and dedicated Clinical Research Associate with qualified experience for more than 7 years in handling and managing all phases of clinical trials.

I have extensive experience in managing clinical trials, encompassing tasks such as investigator selection, patient recruitment, and preparing for and attending sponsor and regulatory authority audits, skilled in ensuring comprehensive documentation and maintaining strong relationships with site staff, sponsors, and stakeholders. Over the past seven years I have successfully managed multiple studies across various countries in the Middle East, including Egypt, Kuwait, and the UAE. This enhanced my ability to cultivate a broad therapeutic expertise, spanning areas such neurology, oncology, endocrinology, infectious diseases, cardiovascular health, rare genetic disorders and dermatology.

Overview

7
years of professional experience
5
years of post-secondary education
6
Certifications
4
Languages

Work History

IQVIA
Cairo

Senior CRA
04.2021 - Current

Job overview

  • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
  • Provide monitoring visits and site management for variety of protocols, sites and therapeutic areas
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate quality and integrity of study site practices related to proper conduct of protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
  • •Manage progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Managed project risk by identifying, quantifying and monitoring potential threats.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Generated and upload assay data and communicated results and reports to multi-disciplinary project teams to influence progression in discovery and development.
  • Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
  • Developed solutions by researching advanced technologies, methods for modeling and predicting performance outcomes and innovative approaches for personalized and adaptive user support
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results

MCT-CRO
Cairo

CRA II
04.2020 - 04.2021

Job overview

  • Managed time efficiently in order to complete all tasks within deadlines.
  • Developed strong communication and organizational skills through working on group projects.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Delivered services to customer locations within specific timeframes.
  • Organized and detail-oriented with a strong work ethic.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Excellent communication skills, both verbal and written.
  • Skilled at working independently and collaboratively in a team environment.
  • Paid attention to detail while completing assignments.
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.

MCT-CRO
Cairo

CRA I
03.2018 - 04.2020

Job overview

  • Delivered services to customer locations within specific timeframes.
  • Worked effectively in fast-paced environments.
  • Developed and maintained courteous and effective working relationships.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Participated in team projects, demonstrating ability to work collaboratively and effectively.
  • Gained extensive knowledge in data entry, analysis and reporting.

MCT-CRO
Cairo

CTA
11.2016 - 03.2018

Job overview

  • Strengthened communication skills through regular interactions with others.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Proven ability to develop and implement creative solutions to complex problems.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Worked effectively in fast-paced environments.
  • Worked flexible hours across night, weekend and holiday shifts.
  • Worked well in a team setting, providing support and guidance.

Multi Apex Factory
Cairo

Quality Assurance Analyst in Multi Apex Factory
06.2016 - 08.2016

Job overview

  • Created and achieved product quality objectives and met product specifications.
  • Supported company in maintaining work environment focused on quality, communication, collaboration, integration, and teamwork.
  • Fixed identified issues to increase productivity and boost workflows.
  • Examined events in application log management and monitoring tool to identify root causes for failures.

Education

German University in Cairo
Cairo

Pharmacy Graduate from Pharmacist
09.2011 - 06.2016

University Overview

Skills

Time management

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Additional Information

Additional Information
  • Phase I/III Double-blind Study COVID 19 vaccine in Participants with Conditions Causing Immune Impairment.
  • Phase IIII Pulmonary Arterial Hypertension.
  • Phase II B invasive fungal infections
  • Phase Ill oncology interventional study on non-small cell lung cancer
  • Phase Ill B interventional study therapeutic area Multiple Sclerosis.
  • Phase II A interventional study therapeutic area Beta thalassemia.
  • Phase II interventional study therapeutic area Sickle Cell Anemia.
  • Phase IIIb/IV interventional study therapeutic area Multiple Sclerosis.
  • Non-lnterventional study therapeutic area Multiple Sclerosis.
  • Non-lnterventional study on non-small cell lung cancer &locally advanced or metastatic hepatocellular carcinoma
  • Non-lnterventional study therapeutic area diabetes mellitus.
  • Registry study on patients with locally advanced or Metastatic breast Cancer.
  • Registry study on patients with Gaucher disease.

Accomplishments

Accomplishments

In terms of accomplishments, I have consistently met and exceeded recruitment targets for all of my trials. Additionally, I have earned two recognition awards from the country manager at IQVIA for my and dedication to my work.

Certification

GCP

Interests

Horse back riding

Backpacking

Yoga

CrossFit

Hiking

Timeline

Senior CRA
IQVIA
04.2021 - Current
CRA II
MCT-CRO
04.2020 - 04.2021
CRA I
MCT-CRO
03.2018 - 04.2020
CTA
MCT-CRO
11.2016 - 03.2018
Quality Assurance Analyst in Multi Apex Factory
Multi Apex Factory
06.2016 - 08.2016
German University in Cairo
Pharmacy Graduate from Pharmacist
09.2011 - 06.2016

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Ahmed Osama MassoudSenior Clinical Resrrach Associate