Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Christopher Frank Gaglio

Stamford,CT

Summary

Versatile, highly motivated professional with skills in clinical operations and data management. Proven ability to conduct data management activities and willingness to work with neighboring departments. Consistent success planning and overseeing multiple projects. Excel in collaboration with multidisciplinary professionals. Personable and energetic with strong communication skills. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Sr, Clinical Data Analyst

Sorrento Therapeutics
06.2022 - 04.2023
  • Collaborates and coordinates with Clinical Operations, Biostatistics and Programming to design and implement clinical protocols and data collection systems to support collection, cleaning, and management of subject data
  • Responsible for assisting in the development and oversight of CDM activities and documents that includes but is not limited to Data Management Plans, eCRF Completion Guidelines, Coding Guidelines, and Manual Listing Review Plans
  • Performs advanced aspects of the data cleaning process (including query review, data transfer reconciliations, SAE reconciliation, and medical coding) with a high degree of accuracy and minimal supervision and in accordance with GCPs and SOPs
  • Oversees database design and data cleaning activities of EDC vendor teams from study start up to closeout
  • Designs and develops data entry screen specifications, edit check specifications, and UAT strategies primarily within Medidata Rave
  • Efficiently organizes workload of several simultaneous studies to ensure critical milestones are met, while maintaining an exceptional level a of quality work
  • Effectively communicates and has soft skills that allow open discussions to occur with mindfulness to help teams stay on task and collectively reach decisions
  • Manages data management issues by reviewing protocols for cross-project/program consistency, and identifying standard eCRF modules to meet protocol objectives
  • Collaborates with Biostatistics to ensure all necessary data are captured to support primary, secondary, and exploratory analyses
  • Performs additional related duties as necessary and/or requested
  • Coordinate database development from study start up to closeout with Biometrics, cross-functional, and vendor team members
  • Assist Project Leads with complex data management projects and help to refine processes and procedures to increase department efficiency
  • Assist in vendor oversight and obtain full awareness of data workflows to and from the Biometrics teams
  • Participate in a wide range of database design, programming, validation and testing activities
  • Provide creative and innovative strategies to data collection and standardization with both short-term and long-term departmental vision
  • Create and apply standards in data cleaning, trend analysis and coordination of cross functional participation in data review

Clinical Trial Associate

Cortexyme
06.2020 - 02.2022
  • Prepares, handles, distributes, files and archives clinical documentation and reports
  • Maintain the internal Trial Master File (TMF) in accordance with the DIA's reference model and periodically reviews the TMF(s) being maintained by the Contract Research Organization (CRO) to ensure accuracy, completeness, and adherence to the DIA's reference model
  • Generated TMF reports to assist with collecting essential documents from investigational sites
  • Assisted in reviewing, QC, uploading, and final reconciliations of essential documents (i.e., FDA 1572 form, delegation log, financial disclosure form, etc)
  • Sat up placeholders for confirmed monitoring visits in the TMF
  • Taking and issuing meeting agendas and minutes for designated clinical team meetings
  • Maintains tracking information for study activities
  • Schedules meetings with internal and external teams, as needed
  • Partners with other functional areas as needed, for example tracking clinical sample shipment to central labs
  • Assists Clinical Research Associates with monitoring of data including query resolution
  • Collaborated with the Clinical Project Lead on the development of certain study-specific plans and/or processes
  • Worked with internal and external team members (i.e., Clinical Data Management, CRO/Vendors, and Medical Monitors) to deliver high quality trial execution
  • Completes assigned responsibilities in a quality and timely manner
  • Perform administrative tasks to support team members with clinical trial execution, as needed
  • Worked closely with central lab vendor to organize the shipment of testing kits and shipment supply orders
  • Communicated with the central lab project manager on any pending study related issues
  • Reviewed issues, discerned trends, and provided appropriate updates to the study team
  • Assisted start-up assignments for two new studies, including routing CDAs for signatures, creating start-up trackers (ADI Log, FAQ Tracker, Training Matrix, Training Tracker, Feasibility Questionnaire trackers, and Start-up Tracker)
  • Adhered to ICH Good Clinical Practice (GCP) guidelines and complied with Cortexyme's Standard Operating Procedures

Clinical Data Analyst I

Samumed
04.2019 - 03.2020
  • Assisted with the maintenance of data collection and cleaning for clinical trials
  • Included data listing reviews and third-party vender data reconciliation
  • Performed query management via issuing and resolving queries to ensure proper site/CRA action performed per protocol and company guidelines
  • Proactively reached out to others cross-functionally to assist with company business projects/initiatives
  • Provided Input and review of Data Management Plans, eCRF Completion Guidelines, and Manuel Review Listings Plans
  • Supported the Project Lead in reviewing draft listing for production and maintaining study documents in eTMF
  • Trained on Central Monitor activities to support Risk Based Monitoring

Clinical Trial Administrator

Xencor
03.2019 - 04.2019
  • Support the clinical operations team with Veeva Vault upgrades
  • Assist the clinical operation staff with trial administration activities
  • Perform maintenance of logs which may include trial feasibility, trial tracking, and monitoring visits
  • File essential regulatory documents including electronic filing.

Intern/Medical Writer

Integra Clinical Research & Technology
02.2019 - 03.2019
  • Nutraceutical company focused on CBD research
  • Conducted research for the study design and assisted with protocol writing
  • Assisted with site procurement and site training.

Clinical Research Assistant

BreakThrough Clinical Trials LLC
11.2018 - 02.2019
  • Assisted in patient recruitment and site selection visit preparation
  • Supported lead study coordinator on source documents, clinical trial operations, regulatory filings and submissions
  • Assisted psychometric raters with conducting assessments
  • Other assignments included source document creation, data entry, and SDV/SDR.

Research Assistant

University of Hartford
09.2017 - 12.2017
  • Completed systematic review on medication vs
  • Alternative therapies for traumatic brain injury treatment.

Yale University, Post-Baccalaureate Research Fellowship
07.2015 - 01.2016
  • Contributed to a broad range of human laboratory studies as part of an interdisciplinary team
  • Shadowed research staff to master consenting process, HIPAA-related confidentiality, psychiatric disorder evaluation, assessment of cognitive functions, and evaluation of drinking and smoking behavior
  • Screened subjects by phone, cleaned data, and accompanied subjects to research-related appointments
  • Key Accomplishments:
  • Prepared manuscripts and completed literature reviews
  • Evaluated medication effects on in-vivo smoking and drinking behavior
  • Certifications & Training
  • Basic First Aid | Adult CPR (w/AED) | Compliance Assessment | HIPAA Privacy and Security Training
  • Blood Bourne Pathogens | Yale University HIPAA Attestation | Clinical Research Management |
  • Clinical Research Associate / NIH-ICH-GCP (E6R2) / UCSD Clinical Trials Design and Management / Introduction to SQL

Education

Master of Science - Neuroscience

University of Hartford
West Hartford, CT
05.2018

Bachelor of Arts - Psychology

Roger Williams University
Bristol, RI
05.2015

Skills

  • Data Cleaning
  • Clinical Operations
  • Data Entry
  • Data Tracking
  • Clinical Development and Operations
  • User Acceptance Testing (UAT)
  • Clinical Trials and Research
  • FDA Compliance
  • Study Protocols
  • Clinical Data Collection
  • HIPAA Guidelines

Certification

  • Clinical Research Associate
  • UCSD Clinical Trials Design and Management
  • Introduction to SQL

Timeline

Sr, Clinical Data Analyst

Sorrento Therapeutics
06.2022 - 04.2023

Clinical Trial Associate

Cortexyme
06.2020 - 02.2022

Clinical Data Analyst I

Samumed
04.2019 - 03.2020

Clinical Trial Administrator

Xencor
03.2019 - 04.2019

Intern/Medical Writer

Integra Clinical Research & Technology
02.2019 - 03.2019

Clinical Research Assistant

BreakThrough Clinical Trials LLC
11.2018 - 02.2019

Research Assistant

University of Hartford
09.2017 - 12.2017

Yale University, Post-Baccalaureate Research Fellowship
07.2015 - 01.2016

Master of Science - Neuroscience

University of Hartford

Bachelor of Arts - Psychology

Roger Williams University

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Christopher Frank Gaglio