Data Analyst Management
Resume:
Naseem Buckley
*********@******.***
*********@*****.***
PROFESSIONAL EXPERIENCE
COMPLIANCE OPERATIONS and CERTIFICATION PLATFORM CONSULTANT - STRIKE GRAPH (JULY 2024 - CURRENT)
• Provide businesses with a compliance operation and certification platform that empower them to build trust and unlock revenue at a fraction of the cost and time of traditional solutions
• Offer an easy, flexible security compliance solution that scales efficiently with business needs — from SOC 2 to ISO 27001 to HIPAA to GDPR and beyond
REMOTE CONSULTANT for the Aga Khan University Hospital (January 2024 - July 2024)
Clinical Trial Management System (CTMS) and EHR Integration
• CTMS Vendor Research Researching potential CTMS vendors to check compatibility with the Meditech Electronic Health Records (EHR) and countries of operation
• CTMS Vendor DEMOS: Arranged and Scheduled demos with Advarra ONCORE and ORACLE CTMS groups to evaluate their user interface, features, and ease of use
• Involved end-users (doctors, administrators) to assess usability
• Interoperability: Ensuring that the vendor’s system can integrate with existing hospital systems (e.g., lab systems, billing).
• Checking about data exchange standards (HL7, FHIR)
• Scalability and Future Needs: Consider long-term scalability. Will the solution accommodate growth?
• Discussing customization options and upgrades.
• Security and Compliance: Assess data security measures (encryption, access controls)
• Verify compliance with HIPAA and other regulations
Health Informatics and Health information Technology (HIHIT) Certificate completed
(September 2023 - December 2023)
The University of Texas at Austin, McCombs School of Business, Austin, TX
The Health Informatics & Health Information Technology (HIHIT) Certificate is a 9-week program designed to prepare post-baccalaureate students for a variety of careers in Health IT. The program includes
four courses and hands-on training with electronic health record software systems, including a working health information exchange (HIE). Data Analysis using SQL and Tableau.
Cybersecurity in Healthcare Certificate (July 2023)
Hospitals and Healthcare Centers - Coursera
Erasmus University Rotterdam
Intuitive Surgical, Santa Clara, CA (June 2023)
Completed Product Complaint Associate Training
University of California, Los Angeles Health (May 2022 – October 2022)
Department of Medicine – Hematology/Oncology
Regulatory Project Manager (remote)
• Responsible for Contract and Budget negotiations between Provider (UCLA) and Payor (Pharma)
• Provided direct and indirect support to clinicians and support staff in the delivery of patient care using ONCORE CTMS and CareConnect (EPIC EHR) system
• COORDINATED and worked with Industry partners to process, review and execute budget and contract amendments in a timely manner
• Followed Regulatory Strategies and achieve Compliance using Clinical Security Requirements
Takeda Pharmaceuticals, Boston, MA (Oct 2020 – March 2022)
Manager, Clinical Data Solutions (remote)
• Conducted oversight of Data Management activities performed by CROs and other 3rd party vendors including IRT, ERT and eCOA vendors
• Activities include from protocol synopsis through database release, submission and CSR Review
• Performed Data Review of SDTM Data and Specifications using Takeda Harmonized Library per the current version of SDTMIG
• Oversaw the Clinical Information Operations to conduct Etera Lab’s Data Review of Study Data
• Worked with CORE (Clinical Operations Repository), to implement Data Quality Checks and CDS Checks for Data Review
• Responsible for Data Review Plan Updates and Execution with CRO and Study Team
• Participated in QC of all Data Management Trial Master File (TMF) documents
• Collaborated and Supported team in Data Review, and Monitoring of Data Management Documents and Activities
• Coordinated to achieve Data reconciliation, Database lock and Final reporting
Quark Pharmaceuticals and Pharmacyclics, CA (July 2019 – Dec 2019)
Clinical Data Analyst and Information Specialist
• Extracted data listings for study team review and confirmation
• Developed edit check specifications and performed edit checks using SQL and MS access on CTMS database while reviewing data to manage data discrepancy and maintain data quality.
• Reviewed data listings for duplicate records and incomplete or inconsistent data
• Ran automated QC reports to identify data issues
• Documented data issues and communicated issues to the CTMS study teams
• Supported system validation and user acceptance testing (UAT) by following scripts provided by the CTMS team
• Performed LED data coordination activities and data validation on CDM projects.
CYTEL – Internship Course on Clinical SAS Programming Using SAS® 9.4 (2018)
• Analysis Dataset Creation – CDISC ADaM
• Validation of Analysis Datasets by independent programming
• Merging Datasets for Pharmacokinetic Analysis
AGA KHAN UNIVERSITY HOSPITAL KARACHI, PAKISTAN (October 2017 – Present)
CLINICAL CONSULTANT (Voluntary)
• Working with the Clinical Informatics Group to determine CTMS vendors for EHR Compatibility
• Worked with the site virtually to evaluate their Data Systems and CTMS Needs
• Travelled to AKU Karachi, Pakistan in December 2017 to discuss their needs for a Clinical Trial Management Software
• Connected CTMS Vendors remotely to identify a product that meets the needs of the Hospital
GENENTECH - Roche (Nov 2016 - AUG 2017 and 2019)
DatA AcQUISITION SPECIALIST (DAS): (Nov 2016 – AUG 2017)
• Responsible for Specification, Acquisition, Loading of non-CRF Vendor IxRS, LAB, PK Data Delivery in SAS Dataset Format
• Production of Vendor Specific non-CRF data collection specification documentation including IRT, ERT and eCOA
• Responsible for establishing appropriate transfer methodology with external data provider
• Proactively checked all inbound non-CRF electronic data for any potentially unblinding data as defined in the protocol and ensured study integrity by sequestering unblinding data until data release was authorized
GENENTECH – ROCHE (2007-2015)
CLINICAL Trial Associate (2007 – 2015)
Oncology & ClinPHARM Studies
Clinical Pharmacological Studies from Startup to Closeout (July 2008 – June 2015):
• Initiated Oracle Siebel Clinical Trial Management Systems (CTMS) migration of data entry to Tata Consulting Services (TCS) India in partnership with the CRO
• PROJECT MANAGEMENT: Managed and led Touchpoint (SharePoint) project successfully between in-house study teams and Clinical CRO (Vendor) as part of the Communication Work stream to build an interactive, collaborative, and creative CPET Covance Partnership
• MANAGED and Conducted migration, setup and maintenance of studies from Trial Works to Oracle Siebel CTMS Software systems
• Collaborated and partnered with Product Development IT to achieve smooth EDC RAVE & Trial Works (CTMS) integration by synching Trial Works Visit names with EDC RAVE Visit folders post EDC RAVE go live
• Conducted Trial Works CTMS training of the CRO (US & Global) for the successful implementation of change in Site Payment process for both SHH4489g and SHH4476g Trials
• Participated in UAT (User Acceptance Testing) of IWRS
Immunology: Rituximab Immunology ISTs (Jan 2007 – August 2008)
• Worked closely with Contract and Budget group to start, track and close contract issues with Sites
• Pioneered the Visit Occurred Payment Method for making Site Payments for ISTs which was later adopted by GNE studies with the Financial Management Initiative in Trial Works CTMS
ICONIX PHARMACEUTICALS, Mountain View, CA (February 2006 to January 2007)
(Contract ended due to no funding)
Contract Clinical Study Coordinator
• A Pilot Multi-Center Study Examining the Relationship Between Biomarkers and Rejection and/ or Calcineurin Inhibitor Toxicity (CI Tox) in Kidney Transplant Patients
• Supported and oversaw 12 total and 5 Active Sites
• Conducted Monitoring Visits to Sites (Stanford and UCSF) to ensure CRF data integrity
ADAPTEC, INC. and XPEED INC., San Jose, California (Mar 1999 to Mar 2004)
Software Engineer
• Wrote driver in Linux C for diagnostics of the Adaptec FC-to-SCSI SAN Subsystem
• Ported NDIS 4.0 driver to NDIS 5.0 for Win 2K for Xpeed SDSL Adapter using the Microsoft Visual Studio, SDK and DDK 5.0 environment
MITSUBISHI ELECTRONICS OF AMERICA, Sunnyvale, California 1994 to 1998
Applications Engineer
• Partnered with Microsoft in the development of Windows 95 software interface for Memory and Network Cards
• Worked as a liaison between Microsoft and Mitsubishi Memory Card Design Group in Japan
• Member of Cross functional team: Attended Global Product Meetings in Japan and worked with cross-cultural teams and external partners
EDUCATION:
Training: Cloud Security (Certificate Program) - SIMPLILEARN SKILLUP (December 2024 - Present)
Google Cybersecurity Professional Certificate (2024) IBM and ISC2 Cybersecurity Specialist Professional Certificate (2024)
IBM and ISC2 Cybersecurity Specialist Professional Certificate (July 2024)
Certificate of Revenue Cycle Management Proficiency (CRCMP) training
AI in Healthcare - Stanford University
Electronic Health Records (EHR) Meditech Systems Certificate
University of San Diego – Professional and Continuing Education (January to July 2023)
Certificate in Cybersecurity in Healthcare (Hospitals & Care Centres) – Coursera (May 2023)
Udemy – Certified Electronic Health Records Specialist - April 2022
UCSC Certification Clinical Trials Design and Management (Jan 2005 – Oct 2005)
AcademyX - SQL Scripting Fundamentals
UCSC – EXTENSION PYTHON FOR DATA ANALYSIS
University of Texas at AUSTIN M.S. Biomedical Engineering
NED University of Engineering & Technology
B.S. Electrical Engineering
PROJECT MANAGEMENT Block 1 & 2 GENENTECH-ROCHE
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