Summary
Overview
Work History
Education
Skills
Timeline
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Linda Rodriguez

Linda Rodriguez

Hoboken,NJ

Summary

Approximately 16 years Clinical Research experience including studies in Phases I through IV and the therapeutic areas of Oncology (Solid tumor and Hem - various indications), CNS, Respiratory and GI (Adult and Pediatric). Trial management activities include vendor and budget management. Open to other kinds of opportunities as well, including different fields and types of roles.

Overview

18
18
years of professional experience

Work History

Study Manager

Parexel
12.2022 - 05.2023
  • Research Collaboration studies within Oncology
  • Work with team members to update study documents such as the Data management plan, contract amendments, and data within the trial management tracking systems
  • Review and approve invoices and study payments per the milestones in the contracts
  • Meet with study team members to discuss study status, data transfer timelines, and publication updates.

Project Manager II (Senior Clinical Trial Manager)

ICON plc (formerly PRA Health Sciences)
06.2021 - 07.2022
  • Trial management of Operations activities for Oncology global studies including prostate cancer, multiple myeloma, and lung cancer
  • Manage transition of countries and sites from Sponsor to CRO oversight, post-trial/expanded access programs, and commercial stock
  • Collaborate with QA and medical team on review of protocol deviations and study findings, work with local teams on corrective and preventive actions, and any follow up required per local regulations and ethics committees
  • Clinical trial insurance updates
  • IWRS, EDC, and CTMS data cleaning
  • Work with data management, site management, Stats, and medical team members on data entry and resolution of queries to meet data release timelines
  • Manage vendors such as CRO, epro, IWRS, and lab.

Clinical Trial Manager (contractor)

Planet Pharma, Clinical Dynamix (Allergan/Abbvie)
08.2016 - 06.2021
  • Trial Manager on Pediatric and Adult GI industry sponsored studies, global and local trials
  • Work with lab vendor for study startup, request initial supplies and resupply of lab kits, review of study documents including lab specs and manuals
  • Oversee ECG vendor to ensure sites receive equipment prior to activation and for return of equipment when sites close
  • Collaborate with CRO on items needed for EMEA regulatory submissions and shipment of supplies to sites in Latin America, import and export licenses, release of shipments from Customs
  • Budget forecast and monthly accruals, track actuals and variances and adjust forecast as needed
  • Process invoices for site and vendor payments
  • Review and approval of site advertisements and changes to Informed consents
  • Manage epro vendor to include contract amendments for updates to services provided, work with HEOR to incorporate necessary QOLs, distribution of devices such as tablets and ediaries to sites and patients
  • Update country level Informed Consent Forms (ICFs) for submission to regulatory agencies for changes to protocol amendments, study activities or regulations
  • Work with QA, Compliance, Clinical Scientists, Safety, and Legal for changes to the Informed consent forms due to updates to the Investigators Brochure (IB), protocol amendments, and requests from Institutional Review Boards (IRBs)
  • Lead study start up from Operations perspective - work with start up managers, Monitors, and clinical scientists to ensure all requirements in place for study and site start up
  • Contracts (vendor and sites), IRB approvals (study and site level), site training, essential documents, vendor supplies received at sites prior to Site initiation Visits (SIVs).

Principal Associate

Celgene
10.2015 - 08.2016
  • Coordinate Investigator Initiated Trials in Oncology
  • Manage studies from submission of initial concept, through activation, maintenance, and close-out
  • Coordinate with the Medical Science Liaisons, Disease Leads, and Contract Managers on study activities including protocol and contract amendments and facilitate review by the scientific review committee
  • Interact with sites to collect monthly enrollment updates and request current Regulatory documents
  • Provide instructions for training and access to various systems for drug ordering and review of safety notifications
  • Process invoices per payment milestones in the contract agreement and reconcile the study budget.

Clinical Trial Manager, Clinical Trial Assistant

Aerotek (contractor for Forest Laboratories, Actavis and Allergan)
08.2013 - 10.2015
  • Operations management of Industry sponsored studies, both local and global studies
  • Therapeutic areas include CNS, Respiratory, and GI
  • Trial Master File (TMF) management and Essential document collection
  • Site start-up: Participate in Vendor selection, from review of proposals and bids received to contract execution, submission of study documents to Central IRB for approval
  • Vendor Management: oversight of IWRS, Central IRB, Central Lab, Central ECG and Printing vendor
  • Review of budgets, contracts, and invoices
  • Generate reports from EDC, review data regarding randomization, prior treatment, concomitant medications, and issue queries in EDC for data discrepancies
  • Exposure to Feasibility processes including CDAs, country and site selection, review of Site qualification visit (SQV) reports.

Research Coordinator

NYU Cancer Institute
07.2006 - 10.2011
  • Quality Assurance Coordinator for Internal Audit program, Data Safety Monitoring Board (DSMB) and Phase I/II Committee
  • Audit approximately 15% of patients enrolled onto Investigator-Initiated, NCI and Cooperative Group studies annually
  • Review patient medical records and other source documents, regulatory binders, and data reports for protocol compliance, interim analyses for dose escalation studies and MTD selection

Research Data Associate

NYU Cancer Institute
12.2004 - 02.2006
  • Clinical Trials coordinator for oncology protocols, including chemotherapy and vaccine trials
  • Enter data in EDC for patients enrolled into studies to include concomitant medications, medical history, prior treatment, tumor measurements (RECIST criteria), adverse events (CTCAE), and Dose limiting toxicities (DLTs).

Education

Master of Business Administration - Marketing

Rutgers University

Bachelor of Arts - Psychology

Rutgers University

Associate of Science - Science and Mathematics

Hudson County Community College

Skills

  • Industry sponsored, Investigator Initiated, and Research Collaboration studies, Phases I through IV, Global studies open in every region of the world
  • Managed vendors, budgets, and business processes
  • Study startup, Vendor and site selection, Feasibility, Study maintenance, Data cleaning, and Closeout
  • Electronic Data Capture (EDC) systems such as Oracle Clinical and Rave, Clinical Trial Management Systems (CTMS) such as iMedidata, Electronic Trial Master File systems (eTMF) such as Veeva Vault
  • Bilingual (English - native, Spanish - fluent)
  • Studied Medical Terminology and abbreviations, Biological sciences, Chemistry, Physics, and Psychology

Timeline

Study Manager

Parexel
12.2022 - 05.2023

Project Manager II (Senior Clinical Trial Manager)

ICON plc (formerly PRA Health Sciences)
06.2021 - 07.2022

Clinical Trial Manager (contractor)

Planet Pharma, Clinical Dynamix (Allergan/Abbvie)
08.2016 - 06.2021

Principal Associate

Celgene
10.2015 - 08.2016

Clinical Trial Manager, Clinical Trial Assistant

Aerotek (contractor for Forest Laboratories, Actavis and Allergan)
08.2013 - 10.2015

Research Coordinator

NYU Cancer Institute
07.2006 - 10.2011

Research Data Associate

NYU Cancer Institute
12.2004 - 02.2006

Master of Business Administration - Marketing

Rutgers University

Bachelor of Arts - Psychology

Rutgers University

Associate of Science - Science and Mathematics

Hudson County Community College

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