Nourhan Abouelhagag Shahat
Clinical Data Manager II
Egypt
Summary
I am an experienced Oncology Pharmacist and Clinical Data Manager with over 3 years of experience in clinical data management and a strong background working in hospitals and Contract Research Organizations (CROs). I have contributed to multiple therapeutic areas, with extensive hands-on experience in oncology clinical trials across different phases. Strong knowledge of GCP and Clinical Data Management guidelines, with hands-on experience in data integrity, quality control, and protocol compliance. Detail-oriented and well-organized, able to prioritize tasks in fast-paced clinical research environments. I am a strong communicator and fast learner with proven ability to build effective relationships with investigators, sponsors, managers, and cross-functional teams.
Overview
8
8
years of professional experience
16
16
Certifications
2
2
Languages
Work History
Clinical Data Manager II
DataClin CRO
11.2025 - Current
- Contributed to CRF design, annotation, and completion guidelines; managed CRF flow, data entry, and tracking for paper‑based and EDC studies.
- Built, tested, and validated clinical study databases, including development and validation of edit checks and database specifications.
- Developed and maintained Data Management Plans, data validation plans, and data entry guidelines to ensure data integrity and protocol compliance.
- Oversaw discrepancy management, including query generation, tracking, resolution, and database updates.
Ensured study documents, query responses, and tracking systems were accurate and up to date throughout the study lifecycle. - Performed database coding using standard dictionaries (e.g., MedDRA and WHO), conducted final database QC, and supported database lock and freeze activities.
- Prepared SAE/NSAE listings for reconciliation and supported efficient study start‑up and close‑out activities.
- Participated in sponsor meetings, providing data management updates, addressing sponsor queries, and supporting alignment on study deliverables and timelines.
- Represented Data Management in audits, inspections, and cross‑functional meetings, ensuring compliance with ICH‑GCP, regulatory requirements, and SOPs.
- Coordinated with biostatistics and clinical teams to support data analysis and reporting.
- Mentored junior staff, maintained HIPAA compliance, and safeguarded patient confidentiality.
Clinical Data Manager I
DataClin CRO
09.2023 - 10.2025
- Create project files for new studies and maintain project files for ongoing studies.
- Track, scan, code and retrieve documents as required for project team members.
- Provide Technical support in assigned projects for example download, copy and keeping records of all electronic data.
- Ensure up to date study documents in tracking system.
- Perform first and second entry of clinical trials data into appropriate database as per study specific convention.
- Resolution of received query responses and update the database accordingly.
- Perform early (C activities (query list, Edit checks validation and Database build validation).
- Updating self-confidence correction lists generated in the database.
- Drafting of CRQ annotation.
- Drafting of CRQ completion guidelines.
- Drafting of Data entry guidelines.
- Assist in the drafting of study documents (Data validation plan, validation listing, self-confidence correction plan, Edit checks development plan and Data management Plan).
- Assist in building and testing study database (Paper-based or EDC).
- Perform archive procedures and prepare copies of project files as required by Sponsor.
- Prepare NSAE and SAE listing for reconciliation.
- Database coding using coding dictionaries (e.g., MedDRA, HOBGrug dictionary).
- Perform final Database (C as independent personnel.
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP, local regulatory requirements and GATAC’in SOPs and study specific procedures.
- Complete routine administrative tasks in a timely manner (e.g., Metrics and Reports).
- Respect of Company’s values and code of ethics.
- Perform other duties as assigned.
BCOP Item Writer
Board of Pharmacy Specialties (bps)
08.2023 - 12.2023
- Item writer for the bps Oncology Pharmacy Specialty Exam Program.
Clinical Data Manager Associate (CDMA)
Dataclin CRO
11.2022 - 09.2023
- Create project files for new studies and maintain project files for ongoing studies according to GATAC’in/s SOPs and/or contractual obligation to sponsor.
- Ensure accurate maintenance of files and documents in their specified location according to GATAC’in/s SOPs.
- Track, scan, code and retrieve documents as required for project team members.
- Provide Technical support in assigned projects for example download, copy and keeping records of all electronic data.
- Maintain a working knowledge and ensure compliance with applicable ICH-GCP, local regulatory requirements and GATAC’in SOPs and study specific procedures.
- First and second tracking of received paper CRQs and GCQs.
- Ensure up to date study documents in tracking system.
- Perform first and second entry of clinical trials data into appropriate database as per study specific convention.
- Resolution of received query responses and update the database accordingly.
- Perform archive procedures and prepare copies of project files as required by Sponsor.
- Updating self-confidence correction lists generated in the relevant database.
- Complete routine administrative tasks in a timely manner (e.g., Metrics and Reports).
Oncology Pharmacist
king Faisal Specialist Hospital & Research Center
04.2018 - 08.2022
- Preparing, checking and dispensing of IV admixtures, ICD Grips, chemotherapeutic agents and TPN admixtures.
- Reviewing patients files, preparing of pre and post chemo medications, checking the lab test for each patient before the chemo cycle, double checking for the chemo protocols and make sure that each patient received the correct drug, correct dose and correct cycle.
- Assist in revising and updating the chemotherapy protocols with the clinical pharmacists.
- Preparing Extemporaneous compounding for chemo and non-chemo medications according to physician order.
- Dispensing of medications in unit dose and prepare the daily chemo and non-chemo medications for inpatient units.
- Checking the chemo and non-chemo medications by reviewing and interpreting physician orders, detecting therapeutic incompatibilities and interactions.
- Checking and refilling medications (regular and narcotics) in the Automated dispensing machines.
- Training new pharmacy staff, students and nurses.
- Assisting in clinical trials in oncology department.
- Assist in Clinical research with Dr. Mohamed Alnahed, Study Number: 22011J8.
- King Abdullah Center for Oncology & Liver Diseases
Education
Master's degree - Cancer Sciences
University of Melbourne
Australia01.2022
American Diploma - Clinical Research, Clinical Studies Design, Methods & Analysis
American Association of Continuing Medical Education (AACME)
USA03.2019
Bachelor degree - Pharmacy
Riyadh Colleges of Dentistry And Pharmacy (Riyadh Elm University)
Saudi Arabia12.2016
Skills
- Communication Skills
- Multitasking Skills
- Time Management Skills
- Team work
- High attention to details
- Organizational skills
Certification
- Professional Program in Data Analysis, Machinfy, 2026-01-01
Timeline
Clinical Data Manager II
DataClin CRO
11.2025 - Current
Clinical Data Manager I
DataClin CRO
09.2023 - 10.2025
BCOP Item Writer
Board of Pharmacy Specialties (bps)
08.2023 - 12.2023
Clinical Data Manager Associate (CDMA)
Dataclin CRO
11.2022 - 09.2023
Oncology Pharmacist
king Faisal Specialist Hospital & Research Center
04.2018 - 08.2022
Master's degree - Cancer Sciences
University of Melbourne
American Diploma - Clinical Research, Clinical Studies Design, Methods & Analysis
American Association of Continuing Medical Education (AACME)
Bachelor degree - Pharmacy
Riyadh Colleges of Dentistry And Pharmacy (Riyadh Elm University)
Training And Volunteering
- Volunteer in oncology and clinical Research activities, 2022-07-01, 2022-09-01
- Volunteer in KACOLD Inpatient Pharmacy, Outpatient Pharmacy, Infusion Center and Satellite Pharmacy, 2014-03-01, 2014-12-01
- Internship in Outpatient Pharmacy & Inpatient Pharmacy, 2016-06-01, 2016-09-01
- Trainee in Oncology Clinics, 2016-04-01, 2016-05-01
- Volunteer in Outpatient Pharmacy, 2015-07-01, 2015-08-01, Hurghada, Egypt
Statistical Software
- RedCap
- STATA
- Power BI
- Python
- R