Experience

Ocular Therapeutix, Inc.

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Associate Clinical Data Manager

  • Apr 2022 - Present

  • Assist with the design of the clinical database based on protocol and study needs, including queries and dynamics• Perform User Acceptance Testing of the clinical database• Author or review of study specific DM documentation (DMPs, CCGs, DTAs, EDC specifications)• Perform data cleaning activities for assigned studies• Monitor study progress to ensure successful achievement of study milestones • Assist with the design of the clinical database based on protocol and study needs, including queries and dynamics• Perform User Acceptance Testing of the clinical database• Author or review of study specific DM documentation (DMPs, CCGs, DTAs, EDC specifications)• Perform data cleaning activities for assigned studies• Monitor study progress to ensure successful achievement of study milestones



Worldwide Clinical Trials

• United States
• Research Services
• 700 & Above Employee

• Senior Clinical Data Associate

  • Jul 2020 - Apr 2022

  • To liaise closely with the Data Manager to report trial progress and any issues outstanding.• To attend study update meetings or calls with the trial sponsor.• To assist the Data Manager with the preparation of trial documentation.• To assist the Data Manager to prepare and write the Data Management Plan.• To assist the Data Manager to prepare database and edit check specifications.• To perform post configuration peer review of Study Design document and database specification.• To assist the Data Manager with the creation and validation of Manual and SAS checks.• To assist the Data Manager with the reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory)• To perform verification and User Acceptance Testing of configured databases.• To assist the Data Manager in all data cleaning activities.• To review SAS listings/SAS tables.• Responsible for the registration of users into the EDC system, performing system demonstrations if required.• To create CRF and eCRF completion guidelines, EDC system manuals and access instructions.• To develop a detailed knowledge of assigned trials and to perform duties which are trial specific. E.g. the scanning of CRFs or the processing of cases for adjudication.• To assist with the maintenance of procedure logs, coding schemes, input notes and Data Entry Manuals.• To establish and/or maintain correspondence files with participating centres.• Archiving of trial documentation and (e)CRFs.

• Clinical Trial Associate

  • Apr 2019 - Jul 2020

  • Managed access and some site use for Cenduit (Interactive Response Technology, IRT), ERT System and Bioclinica Imaging Systems.• Provided access for project team members to Clinical Trial Management System (CTMS) and Sharepoint (SP).• Aided and provided solutions for access questions for the Cenduit (IRT), CTMS and SP systems.• Tracked and updated research site statuses, project team members and Clinical Research Associate (CRA) assignments in CTMS.• Created and managed different trackers for Start-Up and Conduct Activities such as a Site Personnel Access Tracker, Site Activation Tracker, Master Global Site List, Frequent Asked Question Log, etc.• Managed, tracked and followed up with project team members and site staff members for attendance to Investigator Meetings (IM) and study wide trainings.• Provided support on an ad hoc basis for Clinical Operations Managers for any special projects that were required during the trial.• Transcribed meeting minutes for Sponsor and internal meetings.



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Trials Assistant II

  • Sep 2018 - Apr 2019

  • Completed administrative clinical tasks such as requests regarding systems access, document collection, and Investigational Product (IP).• Worked with CRAs and sites to complete timely document collection.• Interacted with sites to fulfill site questions and needs.• Used cross checks between regulatory documents to determine missing documents such as Institutional Review Board (IRB) documents and informed consent forms (ICFs).• Reviewed documents to ensure quality content and filed them in a project specific plan.• Used CTMS for tracking site contacts, documents, safety letters, and etc.• Worked with different IRBs for submissions and document collections (Copernicus, Advarra, Western IRB).• Communicated with Project Teams to understand study’s complexities.

• TMF Health Specialist

  • Nov 2017 - Sep 2018

  • Completed TMF Reviews of Core, Country, and Site folders.• Piloted the Targeted Quality Review Process (TQR) for TMF Inspections.• Used cross checks between regulatory documents to determine missing documents such as IRB documents and ICFs.• Filed according to the TMF Reference Model.• Worked with CRAs and sites to complete timely document collection.• Uploaded documents to different database systems such as Intralinks and ELVIS.• Communicated with Project Teams to understand study’s complexities



INC Research

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Specialist I

  • May 2017 - Nov 2017

  • Conducted TMF inspections acting as independent auditors.• Used cross checks between regulatory documents to determine missing documents such as IRB documents and ICFs.• Communicated with Project Teams to understand study’s complexities. • Worked in multiple database such as Veeva Vault, Phlexview, and INC databases.• Uploaded and named documents according project specific plan following a reference model. • Conducted TMF inspections acting as independent auditors.• Used cross checks between regulatory documents to determine missing documents such as IRB documents and ICFs.• Communicated with Project Teams to understand study’s complexities. • Worked in multiple database such as Veeva Vault, Phlexview, and INC databases.• Uploaded and named documents according project specific plan following a reference model.



Chick-fil-A Restaurants

• United States
• Restaurants
• 700 & Above Employee

• Team Leader

  • May 2016 - May 2017

  • Managed logistics, inventory, and team placement to ensure smooth operation.• Demonstrated best practices to set a positive example for co-workers.• Handled customers’ problems pertaining to their orders.• Assisted in troubleshooting operation problems. • Managed logistics, inventory, and team placement to ensure smooth operation.• Demonstrated best practices to set a positive example for co-workers.• Handled customers’ problems pertaining to their orders.• Assisted in troubleshooting operation problems.



North Carolina State University

• United States
• Higher Education
• 700 & Above Employee

• Student Tutor

  • Aug 2014 - Dec 2016

  • Tutored students in chemistry and calculus.• Learn to manage tutoring in both one-on-one settings, and group settings (3-5 students).• Adapted tutoring methods to student’s needs and learning style.• Awarded the Tutor Appreciation award in 2015. • Tutored students in chemistry and calculus.• Learn to manage tutoring in both one-on-one settings, and group settings (3-5 students).• Adapted tutoring methods to student’s needs and learning style.• Awarded the Tutor Appreciation award in 2015.



City of Hickory

• Landscaper

  • May 2014 - Jul 2014

  Collaborated with teammate to manage landscaping needs for the city’s water resourcesImplemented solutions to problems as they arose such as clearing driving paths to worksites Collaborated with teammate to manage landscaping needs for the city’s water resourcesImplemented solutions to problems as they arose such as clearing driving paths to worksites