Nasar Mohammed
Des Plaines,IL
Summary
Dynamic Clinical Data Manager with over9 years of expertise in managing clinical trial data across all phases (I-IV) in diverse therapeutic areas such as Oncology, Immunology, Hematology, Cardiology, Anti-Viral. Skilled in end-to-end clinical trial activities, including study startup, maintenance, and closeout. Proficient in designing eCRFs, creating edit check specifications, data reconciliation, and database locking processes. Strong leadership skills in managing cross-functional teams and CRO partnerships to ensure quality deliverables including critical BLA lock within timelines. Adept at regulatory compliance, including CDISC standards (CDASH, SDTM) and CFR21 PART11 guidelines. Known for excellent problem-solving, communication, and team-building abilities
Overview
10
10
years of professional experience
Work History
Lead Clinical Data Manager (Contract)
Regeneron Pharmaceuticals
02.2021 - 12.2024
- Led end-to-end data management activities for Phase I-IV Oncology & Hematology studies using Medidata Rave, ensuring compliance with SOPs and regulatory standards
- Developed data management documents including Data Transfer Specifications ), eCCGs (electronic Case Report Forms), Edit Check Specifications, DMP (Data Management Plan), and SAE reconciliation plan
- Involved in overseeing external data and developing Data Transfer Specifications for various vendors providing third-party data, including Safety Lab, PK-ADA, and Biomarkers, in clinical studies
- Led database building, validation, and UAT activities, ensuring compliance with SOPs and regulatory guidelines
- Facilitated database lock activities, executing listing reviews, tracking data cleaning progress for interim and final deliverables
- Ensured inspection readiness through thorough reviews of TMF-loaded data management documents
- Worked cross-functionally with Statisticians and Programmers to ensure high quality data output including data cleaning/validation, SAS listings review and TLF dry runs
- Contributed to forecasting and budgeting processes, ensuring accurate allocation of resources and financial planning for data management activities
Lead Clinical Data Manager (Contract)
Astellas
09.2018 - 12.2020
- Performed all clinical data management activities from study start-up to database lock for Oncology & Immunology trials in accordance with Good clinical Practices (GCPs) guidelines and company Standard Operating Procedure (SOP’s)
- Conducted CRO oversight activities, overseeing the training of the staff, and ensuring the data management activities are carried out as per the specifications
- Reviewed clinical data management documents (including submission package), ensuring appropriate quality, scientific content, organization, accuracy, format and consistency
- Ensure compliance with regulatory guidelines and the documentation matrix
- Plan, Aggregate Checks (DM listings), Reconciliation (LAB, SAE, ECG), other reviewers (Biostatistician, Medical Monitor, Client), and ad hoc reports
- Developed database clinical trial data specifications, including eCRF design, user requirements, edit checks, query logic, and data validations
- Coordinated database lock, freeze activities, and QC checks for final analysis
Clinical Data Manager (Contract)
Exelixis Inc
01.2016 - 09.2018
- Acted as primary DM for multiple Phases of Oncology studies
- Provided oversight for CRO activities, ensuring adherence to timelines and quality benchmarks
- Created routine project status reports and data trends to the internal stakeholders and CRO team
- Monitored end to end processes for collection of DM documents, data discrepancies, data query, data listings, SAE identification, data audit, lock and transfer process ensuring alignment with project and regulatory guidelines
- Performed Inspection Readiness Review of Data Management Documents loaded on TMF and ensuring that review comments found are addressed and followed up through resolution
- Supported inspection readiness activities and participated in sponsor and site inspections
- Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock
Clinical Data Coordinator (Contractor)
Quintiles
09.2014 - 12.2015
- Managed data collection and entry for clinical trials across multiple phases, ensuring consistency and compliance with protocol requirements and regulatory guidelines
- Participated in developing Data Management Plan, CRF Completion Guidelines and other DM specific documents
- Performed SAE reconciliation and external vendor data reconciliation and followed with the sites and vendors appropriately
- Facilitated data cleaning up activities including data review and query generation for assigned protocols
- Performed comprehensive data management tasks including data review, from protocol development to completion of a clinical drug or device development program
Education
Master’s - Information Technology and Management
Valparaiso University
05.2018
Bachelor’s - Pharmacy
JNTUH University
05.2010
Skills
- Technical Skills: TMF, CRF specs, DTA/DTS, CCG, QC, DMP, SAE reconciliation, External Vendor Data Reconciliation, UAT, RECIST, Data lock activities
- Tools: Classic RAVE & RaveX, Medrio, Oracle Clinical, InForm, Veeva CDMS & Vault, ClinCapture, IXRS, RTSM, Safety Gateway, Argus, Data Visualization tools (Spotfire, J-Review), SAS basics, MS Office
- Other Skills: MS Office, Project Management
- Electronic data capture
- Data cleaning
- Data reporting
- Data cleaning
- Data reporting
Publications
- A Review of AI-powered Diagnosis of Rare Diseases – Sep2024
- Leveraging AI in Health Informatics for Early Diagnosis and Disease Monitoring – Jan2025
Timeline
Lead Clinical Data Manager (Contract)
Regeneron Pharmaceuticals
02.2021 - 12.2024
Lead Clinical Data Manager (Contract)
Astellas
09.2018 - 12.2020
Clinical Data Manager (Contract)
Exelixis Inc
01.2016 - 09.2018
Clinical Data Coordinator (Contractor)
Quintiles
09.2014 - 12.2015
Bachelor’s - Pharmacy
JNTUH University
Master’s - Information Technology and Management
Valparaiso University
Similar Profiles
Ruan Cox, Ph.D.Ruan Cox, Ph.D.
Associate Director, Strategic Partnerships at Regeneron PharmaceuticalsAssociate Director, Strategic Partnerships at Regeneron Pharmaceuticals
Rebekah DettmerRebekah Dettmer
Manager Investigations, IOPS Investigation Hub at Regeneron PharmaceuticalsManager Investigations, IOPS Investigation Hub at Regeneron Pharmaceuticals
Courtney Bowyer McCollumCourtney Bowyer McCollum
Senior Manager, Market Access Commercial Training at Regeneron PharmaceuticalsSenior Manager, Market Access Commercial Training at Regeneron Pharmaceuticals