eCOA Clinical Data Delivery Consultant

NASEEM HUDA BUCKLEY

eCOA / Clinical Data Delivery Consultant Sponsor-Side Clinical Research Technology

San Jose, CA (Pacific Time) Fully Remote 408-***-**** *********@*****.*** linkedin.com/in/nhbuckley

PROFESSIONAL SUMMARY

Clinical research technology professional with extensive experience across pharmaceutical sponsors (Takeda, Genentech/Roche), a health system (UCLA Health) and international consulting (Aga Khan University Hospital). Hands-on experience overseeing eCOA, IRT and ERT vendors from protocol synopsis through database release; writing eCOA data specifications; integrating Medidata Rave EDC with CTMS; and running user acceptance testing for clinical SaaS systems. Comfortable leading client and vendor meetings, managing expectations, documenting studies accurately and keeping deliverables on schedule. Software engineering background supports quick technical ramp-up on new platforms.

CORE QUALIFICATIONS

• eCOA / ePRO & vendor data: eCOA, IRT/IWRS and ERT vendor oversight, data specifications, transfer methodology, unblinding safeguards

• Medidata Rave EDC: Rave and CTMS integration (visit-folder alignment), UAT, post-go-live support

• Clinical software delivery: requirements and specifications, UAT scripts and execution, validation, user training, system migration

• Project & client management: multi-study coordination, milestones, risk and issue tracking, sponsor/CRO/vendor communication, contract and budget negotiation

• Clinical research knowledge: GCP/ICH, FDA-submission studies (Phase I–III, oncology, immunology, transplant), eTMF/TMF quality control

• Tools: Medidata Rave, Veeva Vault (eTMF/CTMS), Oracle Siebel CTMS, ONCORE, Epic, SQL, SAS, Tableau, SharePoint, MS Excel/Access

PROFESSIONAL EXPERIENCE

Compliance Platform Consultant Aug 2024 – Present

Independent / Strike Graph (Remote)

• Client advisory: Help businesses adopt a SaaS compliance and certification platform that scales with business needs, from SOC 2 to ISO 27001, HIPAA and GDPR.

Healthcare IT and EHR Integration Consultant Jan 2024 – Jul 2024

Aga Khan University Hospital, East Africa and Pakistan (Remote)

• Client-facing consulting: Evaluated CTMS vendors for compatibility with the Meditech EHR; arranged and led demos with shortlisted vendors (Advarra, Oracle) and engaged end users (physicians, administrators) on usability.

• Technical assessment: Assessed interoperability with hospital systems (HL7, FHIR), scalability, customization and upgrade options, data security (encryption, access controls) and HIPAA compliance for each vendor.

Health IT Training and Certification Jan 2023 – Dec 2023

University of Texas at Austin (McCombs); University of San Diego; Intuitive Surgical; Coursera

• HIHIT Certificate (Sep–Dec 2023): Completed the UT Austin Health Informatics & Health IT program, with hands-on EHR software and a working health information exchange (HIE); data analysis using SQL and Tableau.

• EHR and security: Earned an Electronic Health Records (MEDITECH) Systems certificate through University of San Diego Professional and Continuing Education (Jan–Jul 2023); completed a Cybersecurity in Healthcare certificate (Coursera)

• Intuitive Surgical (Jun 2023): Completed Product Complaint Associate training.

Regulatory Project Manager, Hematology/Oncology May 2022 – Oct 2022

UCLA Health, Department of Medicine (Remote)

• Sponsor relationship management: Negotiated contracts and budgets between UCLA and pharma sponsors; processed and executed amendments on time.

• Systems: Supported clinicians and study staff using ONCORE CTMS and CareConnect (Epic); followed regulatory strategies and clinical security requirements.

Manager, Clinical Data Solutions Oct 2020 – Mar 2022

Takeda Pharmaceuticals, Boston, MA (Remote)

• Vendor oversight: Oversaw CROs and third-party vendors, including IRT, ERT and eCOA vendors, across the full study lifecycle from protocol synopsis through database release, submission and CSR review.

• Delivery and quality: Owned Data Review Plan updates and execution with the CRO and study team; coordinated data reconciliation, database lock and final reporting.

• Data review: Reviewed SDTM data and specifications against the Takeda Harmonized Library and SDTMIG; implemented data quality and CDS checks in CORE (Clinical Operations Repository).

• Cross-functional leadership: Oversaw Clinical Information Operations in the review of Altera Lab study data; collaborated with study teams on monitoring of data management documents.

• Compliance: Performed QC of Data Management Trial Master File documents in Veeva Vault.

Clinical Data Analyst and Information Specialist Jul 2019 – Dec 2019

Quark Pharmaceuticals and Pharmacyclics, CA

• UAT and validation: Supported CTMS system validation and UAT using provided scripts; developed edit check specifications and ran SQL / MS Access edit checks; documented data issues and communicated them to study teams.

Clinical Data Programming Training 2018

Cytel; AcademyX; UCSC Extension

• Clinical SAS Programming internship course, Cytel (SAS 9.4): Created CDISC ADaM analysis datasets, validated them by independent programming, and merged datasets for pharmacokinetic analysis.

• SQL and Python: Completed SQL Scripting Fundamentals (AcademyX) and Python for Data Analysis (UCSC Extension).

Data Acquisition Specialist Nov 2016 – Aug 2017

Genentech – Roche, CA

• eCOA specifications: Produced vendor-specific non-CRF data collection specifications for IRT, ERT and eCOA; defined acquisition and loading of vendor data in SAS dataset format.

• Vendor management: Established data transfer methodology with external data providers.

• Study integrity: Checked inbound electronic data for potentially unblinding information and sequestered it until release was authorized.

Clinical Trial Associate, Oncology & Clinical Pharmacology 2007 – 2015

Genentech – Roche, CA

• Medidata Rave integration: Partnered with Product Development IT to integrate EDC Rave with Trial Works CTMS, synchronizing CTMS visit names with Rave visit folders after Rave go-live.

• Project management: Managed and led the Touchpoint (SharePoint) project between in-house study teams and the clinical CRO, building a collaborative communication workstream for the partnership.

• Training and change management: Trained US and global CRO staff on Trial Works CTMS to implement a new site payment process across two trials; piloted the Visit Occurred payment method later adopted by other studies.

Earlier Experience

• Contract Clinical Study Coordinator, Iconix Pharmaceuticals: Supported and oversaw 12 sites (5 active) in a multi-center kidney transplant biomarker study; conducted monitoring visits at Stanford and UCSF to ensure CRF data integrity.

• Software Engineer, Adaptec / Xpeed; Applications Engineer, Mitsubishi Electronics of America: Developed Linux and Windows device drivers; partnered with Microsoft and global cross-cultural teams on software interfaces.

EDUCATION & CERTIFICATIONS

• M.S. Biomedical Engineering, University of Texas at Austin

• B.S. Electrical Engineering, NED University of Engineering & Technology

• AI in Healthcare, Stanford University Clinical Trials Design and Management, UCSC Extension

• IBM Cybersecurity Analyst Professional Certificate (in progress)

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