Summary
Overview
Work History
Education
Skills
Certification
Timeline
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Luke Luciano

Seattle,WA

Summary

Experienced Clinical Operations & Medical Information Specialist with 7+ years in medical affairs, clinical operations, and clinical trial and medical affairs documentation oversight. Skilled in Veeva Vault system configuration and administration, ICH-GCP compliance, TMF Reference Model, and system process improvement. Proven ability to maintain and optimize electronic clinical documentation systems and document workflows, ensure inspection readiness, and facilitate continuous improvement of systems.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Independent Contractor

Corvus Pharmaceuticals
07.2024 - 03.2025
  • Supported development and administration of Veeva Vault electronic Trial Master File platform
  • Supported development and administration of Veeva Vault Randomization and Trial Supply Management (RTSM) platform
  • Supported development and administration of Veeva Vault Clinical Data Management System (CDMS)
  • Supported development and administration of custom Clinical Trial Management System (CTMS) based on Edetek platform and migration to Veeva CTMS to align with clin ops business needs.

Medical Information Ops Associate Manager

Seagen/Pfizer, Inc
03.2022 - 06.2024
  • Configured and analyzed Veeva Vault Medical features, ensuring seamless integration and functionality
  • Led Veeva Vault platform projects, driving measurable improvements in system performance
  • Managed Medical Information Cloud (Salesforce System), resolving user access problems, data quality challenges, integration errors, and difficulties with reporting analytics leading to improved systems use
  • Managed User Access control systems (access authorization, activation and deactivation)
  • Identified and mitigated risks within Veeva Vault, ensuring system reliability and compliance
  • Supported Veeva Vault system change control and validation documentation
  • Assisted regulatory affairs in dossier archiving and IND submissions using Veeva RIM
  • Managed product metrics using PowerBI platform to track product/drug inquiries throughout the US and Canada.
  • Assisted clin ops team with Veeva CTMS configuration as the leading Veeva suite expert between departments

Medical Information Ops Specialist, Medical Affairs

Seagen/Pfizer, Inc
10.2020 - 03.2022
  • Configured and analyzed Veeva Vault MedComms features and integrations, ensuring seamless operations
  • Led projects to enhance Veeva Vault platform, driving measurable improvements in system efficiency
  • Troubleshoot and resolve issues in Medical Information Cloud, ensuring timely delivery of Med Info requests
  • Performed user account maintenance, generated reports, and managed workflows for Veeva Vault
  • Supported implementation and validation of Veeva Vault, ensuring compliance and functionality
  • Drove platform improvement projects, identifying and implementing strategic enhancements to boost efficiency and user experience.

Clinical Trial Associate, Clinical Operations

Omeros Corporation
03.2019 - 10.2020
  • Conducted quarterly reviews of eCRFs and updated query listings, ensuring data accuracy and compliance
  • Developed and maintained eTMF index, aligning with TMF Reference Model and study-specific requirements
  • Managed essential documents for 6 US sites within Veeva eTMF, ensuring completeness and quality
  • Reviewed and approved ICFs, 1572s, and protocol signature pages, ensuring regulatory compliance
  • Participated in weekly CRO and vendor meetings, coordinating and streamlining clinical operations
  • Ensured eTMF compliance with TMF Reference Model, supporting audits and inspections
  • Managed Medidata CTMS system for document and submission tracking.

Clinical Operations Assistant

Omeros Corporation
06.2018 - 03.2019
  • Served as primary contact for clinical site research staff, ensuring timely document collection
  • Maintained and updated internal eTMF documents list, supporting on-site CRAs and study teams
  • Ensured compliance with TMF Reference Model for CRO eTMF indices
  • Reported eTMF status weekly using metrics, sharing updates at Study
  • Management Team meetings
  • Collaborated with clinical study teams to ensure on-site CRA activities adhered to monitoring plans and SOPs
  • Streamlined eTMF processes, enhancing documentation efficiency and regulatory compliance.

Seattle Genetics Intern

Seattle Genetics
06.2017 - 03.2018
  • Shadowed Clinical Trial Associates performing their daily duties (e.g., collection of essential documents for the eTMF, site communicating, ensuring protocol adherence, site training)
  • QC’d patient visit data through Rave EDC and eCRFs

Education

Bachelor of Arts and Science - Psychology & Biology

University of Washington
Seattle, WA

Skills

  • Veeva Vault administration
  • Clinical data management
  • Project management
  • Regulatory compliance
  • Data analysis
  • User access management
  • Risk assessment
  • System integration
  • Data quality control
  • Documentation management
  • Clinical operations coordination
  • Effective communication
  • Problem solving
  • Business development
  • Vendor management
  • Performance metrics

Certification

Vault Platform Associate Administrator – Veeva Vault Systems

Salesforce Certified Administrator

Timeline

Independent Contractor

Corvus Pharmaceuticals
07.2024 - 03.2025

Medical Information Ops Associate Manager

Seagen/Pfizer, Inc
03.2022 - 06.2024

Medical Information Ops Specialist, Medical Affairs

Seagen/Pfizer, Inc
10.2020 - 03.2022

Clinical Trial Associate, Clinical Operations

Omeros Corporation
03.2019 - 10.2020

Clinical Operations Assistant

Omeros Corporation
06.2018 - 03.2019

Seattle Genetics Intern

Seattle Genetics
06.2017 - 03.2018

Bachelor of Arts and Science - Psychology & Biology

University of Washington

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