Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Caterina Beddia, B.A

Caterina Beddia, B.A

Montreal,QC

Summary

Clinical Research/ Life Sciences professional with over 15 years of experience as a TMF SME in Phase I-IV clinical trials, at Sponsor, Biotech and CRO level, dedicated to TMF management, oversight and implementation, supporting audit/inspection activities and ensuring Inspection Readiness of TMF through key metrics and cross functional team collaboration and training, with an extensive knowledge of GCP and ICH guidelines.

Overview

17
17
years of professional experience

Work History

Head of TMF Solutions Consulting

MONTRIUM
08.2022 - 03.2023
  • Provided expert support and guidance to frontline representatives throughout sales process.
  • Participated in 5-10 customer calls per week providing TMF SME support.
  • Responsible for overall quality of how Montrium products and services were presented to prospective customers.
  • Provided live demonstrations, and participated in customer inquiries and questions to trainings, presentations, and free trials.
  • Played key strategic role in development of tools, processes, and systems for sales group in presenting value of products and services.
  • Responsible for communication of market intelligence back to product, engineering, and services teams
  • Presenter in live event (LinkedIn) TMF webinars, workshops
  • Managed timeline and deliverables for RFI/RFP

Manager, ETMF Operations

INNOVADERM RESEARCH, INC.
08.2021 - 09.2022
  • Successfully Initiated monthly one on one calls with each team member (15 remote reports) in eTMF Operations group, instituted team building activities and bi-weekly group “coffee talk” calls, improving team morale and cohesiveness.
  • Improved KPI compliance, efficiency, accuracy, timeliness, completeness, quality of TMF, and overall inspection readiness by 18% by using metric reports and developing new TMF practices, tools, processes, Work Instructions, SOPs and training materials while keeping within budget, and in compliance with GCP and ICH guidelines.
  • Initiated new process for startup meetings among cross functional teams improving timeliness of start-up activities i.e., eTMF configuration (reference model) and study specific TMF Management Plan
  • Created and implemented new process for TMF completeness checks, improving accuracy and timeliness and compliance with TMF management plan.
  • Oversaw successful processing of 1000+ TMF documents over one-week period in preparation for sponsor audit.
  • Identified TMF trending issues/concerns and risk and successfully executed resolutions and course of actions.
  • Successfully negotiated with eTMF system vendor to alter SOW template to reduce cost of added sites.
  • Assigned resources across 30 Phase II-IV clinical studies for start-up, maintenance, and close-out of TMF across all studies and programs.
  • Participated in project Kick-off meetings, client audits, regulatory agency inspections, bid defense and other project related meetings according to company / client needs.
  • Interviewed, hired, and trained 4 new employees in 1 year.

Sr. Clinical Trial Coordinator for ETMF

PRA Health Sciences (assigned To Merck)
01.2017 - 08.2021
  • Subject Matter Expert for eTMF and Veeva Vault System
  • Performed project management duties as Country Champion for eTMF Out -Tasking activities
  • Collaborated with Quality Assurance Management Team for all compliance issues and updates and supporting of audit/inspection activities
  • Review/QC/Uploaded and finalized documents through workflows in Veeva Vault system for eTMF
  • Presented process updates and new information for all eTMF/Veeva Vault users in Canada
  • Collaborated with Essential Document Management group for system and document resolutions.
  • Collaborated with all internal roles for process and procedure relating to eTMF.
  • Prepared Global Job Aid for filing of documents from un-blinded team space.
  • Provided support and new employee training to all Canadian eTMF users on Veeva eTMF and Essential Document Process.
  • Performed monthly QC of Canadian eTMF.
  • Wrote TMF Quarterly Newsletter

Regulatory Clinical Trial Coordinator

PRA Health Sciences (assigned To Merck)
03.2016 - 12.2016
  • Performed investigative site recruitment/feasibility, essential document collection and review.
  • Tracked clinical status, and in-house site management activities in accordance with Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements.
  • Ensured that Serious Adverse Report Line Listing (SAR LL) were sent to sites and TMF in timely manner.
  • Kept Serious Adverse Report Line Listing (SAR LL) tracker up to date.

Project Assistant

Telesta Therapeutics Inc.
08.2006 - 03.2016
  • Appointed role of “Book Partner” for Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee meeting with FDA.
  • Instrumental in successful conduct of mock FDA cGMP audit, assisting QA/QC team in providing documents as requested by auditor.
  • Created filing process and folders for paper Trial Master Files for Phase III, bladder cancer clinical trial and prepared and shipped ISF to sites.
  • Responsible for maintaining supportive Clinical Research/Regulatory Biologics Licensing Agreement submission-related document files.
  • Tracked Regulatory documents and correspondence with Regulatory authorities.
  • Liaised with sites/investigators for trial related issues and documentation.
  • Prepared various trial related correspondence

Education

Bachelor of Arts - Sociology

Concordia University
Montreal, QC

Skills

  • Metrics
  • Inspection readiness
  • eTMF Systems
  • GCP/ ICH guidelines
  • ALCOA
  • TMF Reference Model
  • Team Leadership
  • Clinical Trials
  • Process Improvement Strategies
  • Client Relations
  • Employee Motivation
  • Presentations
  • Training
  • Product Demo
  • Microsoft Office
  • Problem Solving

Accomplishments

As an eTMF Operations Manager:

  • I implemented new processes and procedures, created new Work Instructions, and authored new SOPs, improving efficiency, accuracy, timeliness, quality and completeness of TMF.
  • Broke down silos, bridging the gap between cross functional teams, improving communication and collaboration resulting in quicker turnover times between submission and final publishing of documents in the TMF.
  • Improved key metrics in quality, timeliness, and completeness of the TMF and overall inspection readiness.


As a Sr. Clinical Trial Coordinator for TMF:

  • I directly contributed to Merck Canada’s success in achieving the number one spot Globally for Merck eTMF, in terms of quality and compliance.
  • As country champion, I successfully led the Merck Canada team in achieving the go live start date on time and on budget for new TMF “out-tasking” initiative.
  • I was the driving force behind successful creation and implementation of process improvement for CTRA eTMF submissions, increasing efficiency, productivity, and enforcing correct Merck process and procedure in 2019.
  • I received Merck Honorable Mention “Leading by Example” award for PRA in 2021
  • Received the Award of Excellence for Outstanding work accomplished by the Canadian TMF Team 02 May 2018.

Timeline

Head of TMF Solutions Consulting

MONTRIUM
08.2022 - 03.2023

Manager, ETMF Operations

INNOVADERM RESEARCH, INC.
08.2021 - 09.2022

Sr. Clinical Trial Coordinator for ETMF

PRA Health Sciences (assigned To Merck)
01.2017 - 08.2021

Regulatory Clinical Trial Coordinator

PRA Health Sciences (assigned To Merck)
03.2016 - 12.2016

Project Assistant

Telesta Therapeutics Inc.
08.2006 - 03.2016

Bachelor of Arts - Sociology

Concordia University

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Caterina Beddia, B.A